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Sep 1, 2015
09/15
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we have this: to to and called project fda which is centered around fda reforms. that has probably been one of the most productive areas at the manhattan institute in the sense that i don't know of any other think tank doing the kind of work the manhattan institute is doing on this issue. the question we will talk about today is one of the most interesting areas in terms of how we think about how to reform the fda. people always complain that the fda is too slow in approving innovative, new treatments. comef the issues that has up recently is this area of precision medicine. there are these things called biomarkers. when you go get your cholesterol checked at the doctor's office, that is a biomarker. that's what we mean. a biomarker is a lab test. it is something we use to correlate something going on your body with a particular outcome of disease. in the case of cholesterol, there is decades of research that indicate the high cholesterol levels, particularly a low density level protein or are highlylevels correlated to heart disease and heart attacks and other pr
we have this: to to and called project fda which is centered around fda reforms. that has probably been one of the most productive areas at the manhattan institute in the sense that i don't know of any other think tank doing the kind of work the manhattan institute is doing on this issue. the question we will talk about today is one of the most interesting areas in terms of how we think about how to reform the fda. people always complain that the fda is too slow in approving innovative, new...
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Sep 4, 2015
09/15
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paul: the fda is actually necessary. emil: i think they need to help recruit more people that are connected to the academic world as they were when they had more people which would help them be more creative, connected to the science than they are now. the easiest thing to do to help them get better, i do think they need more funding. i think they need to figure out how to better organize and look for people that can keep connected to what is going on, drive the science down to the review level. i think they need fewer political initiatives on programs where they hire people , and need to get more money into their drug review and the quality of people involved and appropriate as for biomarkers and other things. i think there are ways to make it work and i definitely think it would not work well without them. peter: i don't think there is a single major drug company that would say yes. it would be a stockholm syndrome problem. [laughter] they are well aware that a lot depends on confidence and social ness. i will add that
paul: the fda is actually necessary. emil: i think they need to help recruit more people that are connected to the academic world as they were when they had more people which would help them be more creative, connected to the science than they are now. the easiest thing to do to help them get better, i do think they need more funding. i think they need to figure out how to better organize and look for people that can keep connected to what is going on, drive the science down to the review...
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Sep 22, 2015
09/15
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. >> the acting commissioner of the fda, dr. steve ostroff testified on food safety before a senate committee. he talked about the budget and appropriations process and a proper funding is crucial to food safety. >> good afternoon. eyewitnesses as well in the audience notices hearing will come to order it will focus on the food and drug administration's effort to improve and maintain safety of our food supply, and i thank you, doctor osac complete presents today. mr. taylor, mr. tootle for participating. we are delighted with that and dr. ostroff, i appreciate the warm working relationship we are building and i appreciate the on a number of issues over the last several months, so thank you for the way you're treating me as the new chairman of the subcommittee. you note in your testimony commissioner that nearly one in six americans are victims of foodborne illness each year. americans expected to they purchased at a grocery store or website will be safe and the fda is largely tasked with maintaining that confidence. passage of f
. >> the acting commissioner of the fda, dr. steve ostroff testified on food safety before a senate committee. he talked about the budget and appropriations process and a proper funding is crucial to food safety. >> good afternoon. eyewitnesses as well in the audience notices hearing will come to order it will focus on the food and drug administration's effort to improve and maintain safety of our food supply, and i thank you, doctor osac complete presents today. mr. taylor, mr....
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lyrica is fda-approved to treat this pain. lyrica may cause serious allergic reactions or suicidal thoughts or actions. tell your doctor right away if you have these, new, or worsening depression, or unusual changes in mood or behavior. or swelling, trouble breathing, rash, hives, blisters, muscle pain with fever, tired feeling, or blurry vision. common side effects are dizziness, sleepiness, weight gain and swelling of hands, legs and feet. don't drink alcohol while taking lyrica. don't drive or use machinery until you know how lyrica affects you. those who have had a drug or alcohol problem may be more likely to misuse lyrica. now i have less diabetic nerve pain. and my biggest reason to walk... ...calls me grandpa. ask your doctor about lyrica. you can't breathed. through your nose. suddenly, you're a mouthbreather. a mouthbreather! how can anyone sleep like that? well, just put on a breathe right strip and pow! it instantly opens your nose up to 38% more than cold medicine alone. so you can breathe and sleep. shut your mou
lyrica is fda-approved to treat this pain. lyrica may cause serious allergic reactions or suicidal thoughts or actions. tell your doctor right away if you have these, new, or worsening depression, or unusual changes in mood or behavior. or swelling, trouble breathing, rash, hives, blisters, muscle pain with fever, tired feeling, or blurry vision. common side effects are dizziness, sleepiness, weight gain and swelling of hands, legs and feet. don't drink alcohol while taking lyrica. don't drive...
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Sep 4, 2015
09/15
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the fda did not specifically address fuller's allegations. bard also declined an on-camera interview with nbc news but said any suggestion that the company submitted forged documents to the fda is flatly untrue and stated that all of its filters have been appropriately cleared by the fda based on required and accurate documentation. and now, gloria adams' son kevin says he wants others to avoid her fate. >> this is a great opportunity for me to tell my mom's story and get the word out for her. >> reporter: what would you say to him? >> i'm so sorry. i'm so sorry that that happened to your mother. it failed catastrophically. his mother should have never died because of this product failing. it shouldn't have happened. >> reporter: while bard stopped selling the recovery filter in 2005, more than 34,000 were sold and it was never officially recalled. bard's own records estimate that as of 2006, there was still more than 20,000 people walking around with them implanted in their bodies. experts believe the longer a filter remains implanted, the g
the fda did not specifically address fuller's allegations. bard also declined an on-camera interview with nbc news but said any suggestion that the company submitted forged documents to the fda is flatly untrue and stated that all of its filters have been appropriately cleared by the fda based on required and accurate documentation. and now, gloria adams' son kevin says he wants others to avoid her fate. >> this is a great opportunity for me to tell my mom's story and get the word out for...
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Sep 21, 2015
09/15
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CSPAN2
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. >>> the act commissioner of the fda, dr. stephen ostroff, testified on food safety before senate committee. he talked about the budget and appropriations process and how proper funding is crucial to food safety. >> good afternoon. witnesses -- this hearing will come to order. today's hearing will focus on the fda's evident to maintain safety of our food supply, and i thank you, commissioner as ostroff, for your present here today. we're dr. ostrove, i appreciate the warm working relationship we are develop and i appreciate the conversations and dialogue we have had on a number of fda issues over the last several months. so thank you personally and professionally for the way you're treating me as the new chairman of the subcommittee. you note in your testimony, commissioner, that nearly one in six americans fall victims to food-born illness each year. americans expect the food they purchase at a grocery store or restaurant will be safe next fda is largely tasked with maintaining that confidence. passage of the food safety moo
. >>> the act commissioner of the fda, dr. stephen ostroff, testified on food safety before senate committee. he talked about the budget and appropriations process and how proper funding is crucial to food safety. >> good afternoon. witnesses -- this hearing will come to order. today's hearing will focus on the fda's evident to maintain safety of our food supply, and i thank you, commissioner as ostroff, for your present here today. we're dr. ostrove, i appreciate the warm...
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Sep 19, 2015
09/15
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that is what we do at fda when we're confronted by such problems. i know that mike and his team have embedded this concept in their work to modernize the nation's food safety system through fsma so it can meet the challenges of a new global era. the enactment of fsma was inquestionably the product of foresight and the recognition of common interests. members of congress on both sides of the aisle came together with consumers and food industry leaders to enhance fsma's ability to protect the food supply in a modern diverse world of free flowing commerce. fsma stands for the proposition that the standard across the food system should be to have processes in place that we have learned work to prevent food problems that many food safety producers -- practices that many food safety producers are already implementing. this means having prevention oriented standards in place that are equally applied to domestic and foreign producers, reasonable verification of compliance with those standards, and accountability for those who are unable or unwilling to comp
that is what we do at fda when we're confronted by such problems. i know that mike and his team have embedded this concept in their work to modernize the nation's food safety system through fsma so it can meet the challenges of a new global era. the enactment of fsma was inquestionably the product of foresight and the recognition of common interests. members of congress on both sides of the aisle came together with consumers and food industry leaders to enhance fsma's ability to protect the...
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Sep 15, 2015
09/15
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>> so, fda reviews all electronic transmissions. we utilized things like foreign inspection, domestic inspection, whether it was sampled in another port, all that information is gathered within the predict application and then that shipment will be given a risk score, the higher the risk score the more chances one of these officers will sample that shipment. >> once the fda inspector picks samples for inspection they are sent to a fda lab like this one in irvine california. >> are you making a shrimp smoothie? >> i'm making a shrimp powder. >> its like a magic trick! >> yes. >> the shrimp powder is mixed with a chemical solvent, dried and liquefied again to run through an analyzer. kai wang is a fda chemist. >> so kai the results are in from the test, what are they showing us? >> in this case, the compound i am looking for is nitrofurons. >> and how dangerous is that for human beings? >> nitrofurons are dangerous for human beings because it's carcinogenic. the fda action level for nitrofuron is one parts per billion. one parts per b
>> so, fda reviews all electronic transmissions. we utilized things like foreign inspection, domestic inspection, whether it was sampled in another port, all that information is gathered within the predict application and then that shipment will be given a risk score, the higher the risk score the more chances one of these officers will sample that shipment. >> once the fda inspector picks samples for inspection they are sent to a fda lab like this one in irvine california. >>...
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Sep 16, 2015
09/15
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it's combined, though, with much more overseas presence by fda. so more foreign inspections, more partnership with foreign governments. more investment in foreign food safety capacity where that will contribute to food safety here. all of that-will-we think this tool kit if implemented properly will work to produce that equal rig dltd rigor. >> so will mr. taylor, you men foreign inspections and fisma mandated in 2015, we'd have about 19,000 foreign inspections and i believe the department plans to only conduct 1200. so 19,000 mandated versus 1200. this lack of foreign inspections is adding to the concern that really different standards will be, if you will, practiced in foreign countries because there is not enough inspections to hold them accountable. your thoughts on that. >> you put your finger on a huge challenge. and that is how do we target our resources with the resources we get to do this -- implement this law effectively. so we have increased our foreign inspections from less than 300 before enactment to in the 1200 to 1400 range current
it's combined, though, with much more overseas presence by fda. so more foreign inspections, more partnership with foreign governments. more investment in foreign food safety capacity where that will contribute to food safety here. all of that-will-we think this tool kit if implemented properly will work to produce that equal rig dltd rigor. >> so will mr. taylor, you men foreign inspections and fisma mandated in 2015, we'd have about 19,000 foreign inspections and i believe the...
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Sep 16, 2015
09/15
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the fda action level for nitrofuron is one parts per billion. one parts per billion is the equivalent of looking for one gram of salt in an olympic sized swimming pool. >> wow! so how many parts is this per billion is this result? >> i would say it's about 1 to 2 parts per billion. >> so two grains of salt in an olympic sized swimming pool and you've managed to find it it that vial? >> yeah. >> that's incredible. so that batch of shrimp is not allowed in this country, essentially? >>it's not going to be allowed in this country. >> the fda simply isn't testing enough on the imported market to really find all of these violative residues. >> dr. urvashi rangan headed a study of imported shrimp for the june 2015 issue of the influential magazine "consumer reports." >> of the 205 imported farm samples that we found, 11 of those actually had illegal residues of antibiotics on them. that comes out to about 5% of the imported farmed shrimp samples being contaminated with an illegal antibiotic residue. the fact that the fda only tests about .7 percent of
the fda action level for nitrofuron is one parts per billion. one parts per billion is the equivalent of looking for one gram of salt in an olympic sized swimming pool. >> wow! so how many parts is this per billion is this result? >> i would say it's about 1 to 2 parts per billion. >> so two grains of salt in an olympic sized swimming pool and you've managed to find it it that vial? >> yeah. >> that's incredible. so that batch of shrimp is not allowed in this...
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Sep 22, 2015
09/15
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many of those women will be at that fda hearing in silver spring on thursday, as will bayer as the fdahapes what could be the future of e sure birth control. i'm investigative reporter russ ptacek, wusa9. >> to file a report with the fda or to join the women's group, go to the wusa9 app. if you have a problem or want to volunteer for our call for action team, you can go to www.wusa9.com and click on the call for action tab or you can call our hot line at 301-652- help. >>> tonight we're tracking metro's latest smoke incident, trains are running at full service this evening, but it was commuter chaos for much of the day. a transformer caught fire this morning near the stadium armory station. it caused big backups on the orange, silver and blue lines, many frustrated passengers settling for crowded subtle buses or finding other ways to get to work. >> nobody is speaking, no nothing. >> herd us out here like cattle. >> despite that venting first responders say metro's emergency response was solid. they quickly shut off power to the rail, communicated with the fire department and safely re
many of those women will be at that fda hearing in silver spring on thursday, as will bayer as the fdahapes what could be the future of e sure birth control. i'm investigative reporter russ ptacek, wusa9. >> to file a report with the fda or to join the women's group, go to the wusa9 app. if you have a problem or want to volunteer for our call for action team, you can go to www.wusa9.com and click on the call for action tab or you can call our hot line at 301-652- help. >>>...
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Sep 13, 2015
09/15
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FOXNEWSW
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the fda is trying to clamp down on this and trying to get the plants to good afternoon themselves and trying to clamp down on the imports. i'm dubious about whether -- >> you've got to see a little sticker and sometimes it says, you know, from mexico or from costa rica or some place else. should you only buy what's grown in the united states maybe or -- >> that's not the answer. unfortunately, you don't have much control over this, and this modernization safety for food that went into effect in 2011, i'm not so much optimistic about this because it hasn't been working and the reason is our food chain system is so complex. we get 15% of our food from other country and 300 facilities from the outside are sending us food and if you are thinking by these guidelines you can stop the bad food, retailers and transporters but bottom line be in charge of your own food and what do we do? we've talked about this, wash your hands and clone your vegetables and food thoroughly and keep your meats separate and invest in a good food thermometer at home and make sure you cook your food, your meat to 1
the fda is trying to clamp down on this and trying to get the plants to good afternoon themselves and trying to clamp down on the imports. i'm dubious about whether -- >> you've got to see a little sticker and sometimes it says, you know, from mexico or from costa rica or some place else. should you only buy what's grown in the united states maybe or -- >> that's not the answer. unfortunately, you don't have much control over this, and this modernization safety for food that went...
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Sep 27, 2015
09/15
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we joined by former fda deputy commissioner dr. scott gottlieb.sion on campaign 2016 with run for america cofounder selena gray. she will talk about the influence of super pac's, and efforts by her group to recruit nontraditional candidates for congress. ♪ host: good morning. it is sunday, september twice seven, 2015. welcome to "washington journal." pope francis, today, finishes up his trip to the united states with the mass in philadelphia. president obama will speak at the united nations on monday, so slottedl find it will -- vladmir putin. the house and senate have to pass some sort of funny resolution by september 30 --
we joined by former fda deputy commissioner dr. scott gottlieb.sion on campaign 2016 with run for america cofounder selena gray. she will talk about the influence of super pac's, and efforts by her group to recruit nontraditional candidates for congress. ♪ host: good morning. it is sunday, september twice seven, 2015. welcome to "washington journal." pope francis, today, finishes up his trip to the united states with the mass in philadelphia. president obama will speak at the united...
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Sep 3, 2015
09/15
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onvia: let's bring you in the fda angle. who knew the fda regulated mayonnaise.hey involved in this? that has been an interesting comment that has come up as this has unfolded. standardth the fda has identities for tons of food, dairy and cheese products. we are now finding out mayo as well. they want to make sure when you go to the grocery store and you buy a product, that you have some assurance that it is what it claims to be. that is where they have gone involved. that food ise sure meeting eight certain definition. -- a certain definition. olivia: big companies are worried if you are making mayonnaise without eggs, that is bad news for their business. you think it is the egg companies? >> the associated press reported that the american egg board was pretty involved in a larger campaign to try to discredit our work, paying bloggers who did not disclosed destin not disclose, even paying someone to call whole foods, our good friends there, to attempt to block distribution of our product. good on whole foods, it is a principles centered company, they did not hav
onvia: let's bring you in the fda angle. who knew the fda regulated mayonnaise.hey involved in this? that has been an interesting comment that has come up as this has unfolded. standardth the fda has identities for tons of food, dairy and cheese products. we are now finding out mayo as well. they want to make sure when you go to the grocery store and you buy a product, that you have some assurance that it is what it claims to be. that is where they have gone involved. that food ise sure meeting...
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and the fda simply pulling the medical community back in to say wait a minute.serious complications of these medicines. >> reporter: notice from the fda outlines its intention to take enforcement action against unapproved and miss branned ear drops that contain bense so cane. >> there are a lot of pediatricians, there are a lot of doctors in this country who will say, that the medicines on that list have been effective for their patients. again, the trouble is, that we don't really have hard and fast data to prove that. >> reporter: statement from the fda says many health care professionals are likely not aware of the unapproved status of these drug products and have unknowingly prescribed them because the drugs labels do not disclose that they lack fda approval. some pharmacists have decided to stop selling the ear drugs on their own. >> it's not worth it. now i can't even say it's not going to harm you. >> reporter: worried parents are being advised to call their doctor and consider switching to over the count pain remedies. >> it will be equally as effective
and the fda simply pulling the medical community back in to say wait a minute.serious complications of these medicines. >> reporter: notice from the fda outlines its intention to take enforcement action against unapproved and miss branned ear drops that contain bense so cane. >> there are a lot of pediatricians, there are a lot of doctors in this country who will say, that the medicines on that list have been effective for their patients. again, the trouble is, that we don't really...
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Sep 27, 2015
09/15
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what is the role of the fda and drug pricing?t: the fda has a big influence on the price of drugs because a lot of the pricing is tied to the risk of developing a n needs to go into pay for the development program as well as the continued manufacturing cost. we have seen in recent years the cost of drug development, quite a lot. that has the most impact on the generic drug market were manufacturing costs have been very cheap and ghana. we have seen some inflation in the drug market where one these to cost a couple of cents per 10 or $.15 to manufacture per pill. that is spread over the entire system. talking. scott gottlieb about drug prices. we would love to hear from you .bout your experiences you can call or tweet us. the story that motivated our conversation here on these rise on this price particular drug. they arehe story, protesting a giant overnight increase in the price of the 62-year-old drug that is the standard of care for life treating -- life-threatening parasitic infection. august by ared in startup hedge fund mana
what is the role of the fda and drug pricing?t: the fda has a big influence on the price of drugs because a lot of the pricing is tied to the risk of developing a n needs to go into pay for the development program as well as the continued manufacturing cost. we have seen in recent years the cost of drug development, quite a lot. that has the most impact on the generic drug market were manufacturing costs have been very cheap and ghana. we have seen some inflation in the drug market where one...
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Sep 18, 2015
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tuesday ahead of this is a task with multiple agencies with the fda regulating 80%. continually to make the process and procedure in place it is always a treat as well as the imported strawberry. >> with the food safety laws to look at how we do food safety to spend the resources to retract that down now to make sure we prevent that from occurring it is the better way to do business the law had deliverable and it took longer than they would like the rat the point where the rubber meets the road to require a new way of thinking for food inspectors trained to look for an existing problem instead of seeing that they never materialized in the first place. i know bernie about the processing there would make sure the new rules while minimizing the disruption and so thank you for holding the hearing i'm interested in hearing from above with mrs. >> commissioner ostroff your testimony is day significant number i have extended from the five minutes at that ted >> i share your enthusiasm for the working relationship we have been able to develop the last several months and look
tuesday ahead of this is a task with multiple agencies with the fda regulating 80%. continually to make the process and procedure in place it is always a treat as well as the imported strawberry. >> with the food safety laws to look at how we do food safety to spend the resources to retract that down now to make sure we prevent that from occurring it is the better way to do business the law had deliverable and it took longer than they would like the rat the point where the rubber meets...
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Sep 3, 2015
09/15
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she also says the fda isn't doing its job. >> the system right now is flawed. >> reporter: what is the principal problem with it right now? >> it can't assure protection of safety in devices. >> reporter: the fda declined our interview and said in a statement that it is committed to ensuring that patients have access to safe and effective medical devices, and have established pathways and guidelines to protect the public health. c.r. bard officials including president john wyland also declined our request for an interview. we tried to talk to him while he arrived at work. there are thousands of people with this filter in them. seeing the cameras, he stayed in his car and drove away. bard said all of its filters have been appropriately cleared by the fda, based on required and accurate documentation and when used as instructed they demonstrate significant benefits to patients. but knowing how close she came to death, dodi frolic considers herself lucky. >> sometimes when i tuck my son in, it's a longer hug with, "i'm glad i'm here." >> the question many people may be asking is, how this
she also says the fda isn't doing its job. >> the system right now is flawed. >> reporter: what is the principal problem with it right now? >> it can't assure protection of safety in devices. >> reporter: the fda declined our interview and said in a statement that it is committed to ensuring that patients have access to safe and effective medical devices, and have established pathways and guidelines to protect the public health. c.r. bard officials including president...
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in a statement to nbc news, bard said all of its filters have been appropriately cleared by the fda, based on required and accurate documentation and when used as instructed they demonstrate significant benefits to patients. but knowing how close she came to death, dodi frolic considers herself lucky. >> sometimes when i tuck my son in, it's a longer hug with, "i'm glad i'm here." >> the question many people may be asking is, how this product made it to the market in the first place. tomorrow night we talk to a former company insider who says bard executives ignored her safety concerns and that her signature was forged on a key document submitted to the fda. lester? >> stephanie, we look forward to your next report, thank you. >>> up next an nbc exclusive, the american hero who charged a terrorist wielding an assault weapon on the high speed train to paris. what was going through his mind as he risked his life to start a massacre. >>> later it's what all the buzz is about, kids clamoring to get in, but you better have a book in hand before you hop in this barber's chair. its way into
in a statement to nbc news, bard said all of its filters have been appropriately cleared by the fda, based on required and accurate documentation and when used as instructed they demonstrate significant benefits to patients. but knowing how close she came to death, dodi frolic considers herself lucky. >> sometimes when i tuck my son in, it's a longer hug with, "i'm glad i'm here." >> the question many people may be asking is, how this product made it to the market in the...
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Sep 15, 2015
09/15
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WNYW
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>> since 2009, the fda took control of cigarettes, they're regulated by the fda. so every time a tobacco company needs to put out a new cigarette, they have to prove that they're just like the other cigarettes. they can be different. they can be enhanced flavor-wise. they can have more tobacco, criteria. there were four brands put out by reynolds which the fda is saying take them back. they don't meet the criteria. they're laced with menthol. they have a different distribution system for tobacco. the brands new camel, pall mall and others. the stores have 30 days to have them removed. they're illegal for sale. steve: in general it seems like cigarettes that are trying to make them seem more flavorful, less dangerous. >> look, cigarettes are addictive. nicotine is addictive. they're looking for new customers. new customers basically different colors, different sets, different sassy box. the problem everybody has is teenage smoking which continues to be a problem in young adults. so that's where the fda is stepping in and saying you can't be changing stuff and they'
>> since 2009, the fda took control of cigarettes, they're regulated by the fda. so every time a tobacco company needs to put out a new cigarette, they have to prove that they're just like the other cigarettes. they can be different. they can be enhanced flavor-wise. they can have more tobacco, criteria. there were four brands put out by reynolds which the fda is saying take them back. they don't meet the criteria. they're laced with menthol. they have a different distribution system for...
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Sep 26, 2015
09/15
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it's not to say fda regulation is good or bad. the question is who will serve now in this particular context through this particular legislation. >> since there's no evidence that smoking tobacco can be used without producing this obama's burden of disease, it seems there's this evidence that saying it does produces obamas burden of disease and wire we --ing any other questions why aren't we asking any other questions other than what's the most strategic way to stop in tobacco? mr. brandt: what the strategic and pragmatic approach to making smoke-free --lly genuinely smoke-free. one of the things i found in the book is in many ways, the cigarette was grandfathered. it was a historic product based on a crop grown before europeans even got here. it became an incredible economic engine of the development of the early states. really dealing with a product with this historical weight. i don't think realistically a ban is in our immediate future but we should be looking aggressively at ways of reducing the burden of disease associated w
it's not to say fda regulation is good or bad. the question is who will serve now in this particular context through this particular legislation. >> since there's no evidence that smoking tobacco can be used without producing this obama's burden of disease, it seems there's this evidence that saying it does produces obamas burden of disease and wire we --ing any other questions why aren't we asking any other questions other than what's the most strategic way to stop in tobacco? mr....
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Sep 30, 2015
09/15
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KSTS
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rosario quintanilla/ vocera fda "la mayoria de estos casos se encuentra un ingrediente que es actualmenteea que el ingrediente que se encuentra en un producto que es debidamente recetado por un medico se esta encontrando en un suplemen" la fda advite que conseguir uno de estos productos en una tienda no significa que es seguro pues algunos no necesitan su visto bueno para ser vendidos y varios estan en su lista negra, por eso recomiendan consultar siempre con su medico. blanca-vo ---el proceso del pasaporte mexicano ahora ser ms sencillo, al menos es lo que propone la secretaria de relaciones exteriores que inform que ahora el trmite podr hacerse por internet. ---a traves de twitter, indic que los interesados tendrn la opcin de hacer la cita y pago a partir de este primero de octubre ingresando al portal www. gob.mx. cesar take vo ---el volcan de erupcies este lunes eiando al aire columnasde humo y ceniz que esta maÑana tambien se registraron nuevas explosiones afectando las ciudades de colima y villa de alvarez que amanecieron con lluvia de ceniza... ---las autoridades de proteccion civi
rosario quintanilla/ vocera fda "la mayoria de estos casos se encuentra un ingrediente que es actualmenteea que el ingrediente que se encuentra en un producto que es debidamente recetado por un medico se esta encontrando en un suplemen" la fda advite que conseguir uno de estos productos en una tienda no significa que es seguro pues algunos no necesitan su visto bueno para ser vendidos y varios estan en su lista negra, por eso recomiendan consultar siempre con su medico. blanca-vo...
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Sep 2, 2015
09/15
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WUSA
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so the fda does not actually have the legal authority to pull the stuff off the market. so it's using the bully pulpit instead. one tactic? those warning letters that have now been sent to the five distributors. >>> a county clerk in kentucky faces a contempt of court hearing thursday for refusing to issue marriage licenses to same sex couples. >> under whose authority are you not issuing licenses? >> god's authority. >> kim davis refuses to issue the licenses because she said doing so would go against her religious beliefs. >>> pope francis says he's letting all priests in the upcoming year of mercy absolve what he calls the sin of abortion if a woman seeks forgiveness with a contrite heart. francis says he's met many women bearing the scars of this agonizing decision. pope francis will be in d.c. september 22nd to the 24th and we have an entire section dedicated to his visit on our wusa9 news app. you'll find everything from the pope's schedule to the issues he's expected to address. >>> and a young girl is speaking out after a stranger left a nasty note on her family'
so the fda does not actually have the legal authority to pull the stuff off the market. so it's using the bully pulpit instead. one tactic? those warning letters that have now been sent to the five distributors. >>> a county clerk in kentucky faces a contempt of court hearing thursday for refusing to issue marriage licenses to same sex couples. >> under whose authority are you not issuing licenses? >> god's authority. >> kim davis refuses to issue the licenses because...
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Sep 24, 2015
09/15
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WJLA
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eye 83
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the fda just finished a day of testimony regarding this. women are calling on the fda to pull it. they say it is causing a host of problems like severe pain, bleeding, and weight gain. the panel listened to the women. it is not affected at hand out a ruling. it is suspected -- it is expected to take the information into consideration. enjoyed thee you sunny skies for the last couple of days because things will change. alison: what is the latest? doug: high cloudiness. i think the heavier cloudiness will hold off until the afternoon. we are looking forward to a cloudy, breezy, cool, and perhaps what weekend. -- wet weekend. some sunshine getting through the clouds. temperatures will fall to about 60 degrees for an average overnight low. 5-10.asterly winds at things will be interesting. a development over the next few days due to low pressure that is in setting up the coast of north and south carolina. it's making a move to the west, going to the left-hand side of your screen. at the same time a large area of high pressure is building over canada and new england. it will be the inte
the fda just finished a day of testimony regarding this. women are calling on the fda to pull it. they say it is causing a host of problems like severe pain, bleeding, and weight gain. the panel listened to the women. it is not affected at hand out a ruling. it is suspected -- it is expected to take the information into consideration. enjoyed thee you sunny skies for the last couple of days because things will change. alison: what is the latest? doug: high cloudiness. i think the heavier...
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Sep 19, 2015
09/15
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CSPAN3
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eye 56
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so when they're auditing they would not be doing the same thing an inspector, an fda inspector would be doing in a foreign country. is that -- we >> well, it's different. when you talk about inspection we're used to looking at facilities and conducting a physical exam of a physical place. the aud did term applies to looking at auditing the program, checking the records, being able to get confidence from examining the records and talking to the importer that they are, in fact -- they know what they're doing rand doing the right thing. so it's a records-intensive audit activity that will be a major component of ensuring this is being done properly. >> mr. taylor, thank you. i have more questions but maybe a way to accommodate your schedule is to to to you, and if you're unable to stay for my final round i wouldn't be offended. >> thank you very much, mr. chairman. i wanted to draw attention to the report tt you've all displayed, the 2014 food safety progress report for folks who are numerically challenged, you've boiled it down to happy faces, grim faces and very unhappy faces and the
so when they're auditing they would not be doing the same thing an inspector, an fda inspector would be doing in a foreign country. is that -- we >> well, it's different. when you talk about inspection we're used to looking at facilities and conducting a physical exam of a physical place. the aud did term applies to looking at auditing the program, checking the records, being able to get confidence from examining the records and talking to the importer that they are, in fact -- they know...
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Sep 2, 2015
09/15
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WABC
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say they will no longer offer pure caffeine powder supplements because it is a supplement that the fda cannot ban but they will keep putting pressure on the sellers. >>> well, you can tell from the music that an exciting new season of "dancing with the stars" is upon us. >> i am excited for that music. got me in the mood. >> the rest of the cast members were announced. most of them appeared together for the first time today on "good morning america." here is a look at everyone who will be competing. singers chaka khan and knick carter, tamar braxton and hayes grier and spouses are included, david. >> actress alexa pena vega and her husband and singer andy grammer and kim kohl chack. paula deen, bindi irwin, victor espinosa and one of the men that throat the europe train attack alek skarlatos. >> it premieres monday, september 14th at 8:00 p.m. on channel 7. >> they have a big challenge stepping up and bringing in somebody that -- >> i love this class. >> chaka khan. >> pulled me in right away. paula deen, her personality will be crazy. looks like a good cast. i'm with you, i think the
say they will no longer offer pure caffeine powder supplements because it is a supplement that the fda cannot ban but they will keep putting pressure on the sellers. >>> well, you can tell from the music that an exciting new season of "dancing with the stars" is upon us. >> i am excited for that music. got me in the mood. >> the rest of the cast members were announced. most of them appeared together for the first time today on "good morning america."...
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Sep 11, 2015
09/15
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WJLA
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bare naked says it also follows the fda regulations. cup may not take up a lot of space on your plate, it still offers nutrients boulder brands says it uses the fda guidelines so consumers can compare products easily. becky worley, abc news, new york. >>> so with the series this week, for us morning folks, we've now lost yogurt, granola and muffins. how are we supposed to eat? egg whites? >> with cheddar. >>> or a milkshake. what do you call those, protein shakes. >> even those are fairly fattening, as well. >> apparently you can make it your old granola, old fashioned rolled '80s, dried fruits, dried roted nuts and vanilla. >> it sounds like too much effort for a single guy. >> get to the protein shakes. you like those. >> man what, do we eat now? >> coming up, "insomniac theater.." >> more news straight ahead. hands...where it belongs. olay regenerist. it regenerates surface cells. new skin is revealed in only 5 days. without drastic measures. stunningly youthful. award-winning skin. never settle for anything less. the regenerist coll
bare naked says it also follows the fda regulations. cup may not take up a lot of space on your plate, it still offers nutrients boulder brands says it uses the fda guidelines so consumers can compare products easily. becky worley, abc news, new york. >>> so with the series this week, for us morning folks, we've now lost yogurt, granola and muffins. how are we supposed to eat? egg whites? >> with cheddar. >>> or a milkshake. what do you call those, protein shakes....
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Sep 24, 2015
09/15
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CNBC
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the fda -- getting fda clearances or having insurance companies come in and install incentives, right, and provide coverage and make it sort of -- make it more yub versal across their client base? >> so when i said that there is an era of transformation, it's important that the fda regulate, but at the same time the reimbursement has to come from the government. the government has to really make a stronger push. it's already moving that way, but it's not moving in fast enough. >> this is the type of quality that makes these away wearables a must-have. >> samsung is opening a brand new office in silicon valley, but does it measure up to its piers? we'll grif you a closer look after this break. can it make a dentist appointment when my teeth are ready? ♪ can it tell the doctor how long you have to wear this thing? ♪ can it tell the flight attendant to please not wake me this time? ♪ the answer is yes, it can. so, the question your customers are really asking is, can your business deliver? >> good morning, everyone. the sec is charging michael and his new york-based investment advisory f
the fda -- getting fda clearances or having insurance companies come in and install incentives, right, and provide coverage and make it sort of -- make it more yub versal across their client base? >> so when i said that there is an era of transformation, it's important that the fda regulate, but at the same time the reimbursement has to come from the government. the government has to really make a stronger push. it's already moving that way, but it's not moving in fast enough. >>...
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Sep 12, 2015
09/15
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FOXNEWSW
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. >>> the fda is taking steps to keep our food free of bacteria that can make us sick.rying to insure our safety. >>> a gunman using a busy highway for target practice. police are questioning a person of interest but the danger may not be over. >> it's kindly, spooky, man, you know when people can't drive up and down the interstate unless they're getting shot at. this is pretty dang scary. do you want to know how hard it can be to breathe with copd? it can feel like this. copd includes chronic bronchitis and emphysema. spiriva is a once-daily inhaled copd maintenance treatment that helps open my airways for a full 24 hours. spiriva helps me breathe easier. spiriva respimat does not replace rescue inhalers for sudden symptoms. tell your doctor if you have kidney problems, glaucoma, trouble urinating, or an enlarged prostate. these may worsen with spiriva respimat. discuss all medicines you take, even eye drops. if your breathing suddenly worsens, your throat or tongue swells, you get hives, vision changes or eye pain or problems passing urine, stop taking spiriva respima
. >>> the fda is taking steps to keep our food free of bacteria that can make us sick.rying to insure our safety. >>> a gunman using a busy highway for target practice. police are questioning a person of interest but the danger may not be over. >> it's kindly, spooky, man, you know when people can't drive up and down the interstate unless they're getting shot at. this is pretty dang scary. do you want to know how hard it can be to breathe with copd? it can feel like...
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Sep 28, 2015
09/15
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FBC
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you don't want to eliminate the fda the fda has legitimate role and appropriate role in insuring drugsand effective. they have gone way beyond that like a lot of regulatory agencies they have gone beyond the basics and make it so hard and difficult a lot of good drugs may not make it because they're dropped early on in development because they're so expensive. trish: let me share with you, i like our viewers to see as well, september 21st, in baton rouge, louisiana, hillary clinton rolling out her plan for the pharmaceutical industry. i will add, she managed single-handedly managed to tank biotech stocks on day she did this. listen to this. >> we will start company canning how much youdcapping how much you pay for out-of-pocket for prescription drugs and we hold companies accountable as we work to drive down prices. nobody in america should have to choose paying for medicine they need or paying their rent. trish: i completely agree. nobody should be forced to make that choice. however, avik, that aside, do we run the risk if wee overregulate industry causing a situation where very peop
you don't want to eliminate the fda the fda has legitimate role and appropriate role in insuring drugsand effective. they have gone way beyond that like a lot of regulatory agencies they have gone beyond the basics and make it so hard and difficult a lot of good drugs may not make it because they're dropped early on in development because they're so expensive. trish: let me share with you, i like our viewers to see as well, september 21st, in baton rouge, louisiana, hillary clinton rolling out...
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Sep 16, 2015
09/15
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CSPAN3
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but equally important for your purpose, the people at fda embrace this wholeheartedly. the people who are at the front line in our agency are public health people, you know, enforcement is a tool, and that's been the culture of the agency given the statute we've had and the framework for food safety which has basically been an enforcement and statute oriented organization. on the front line people love that. they would much rather be getting good food safety outcomes and doing public health than try to rack up enforcement numbers. that's not the fundamental mentality of the cadre of people. it's an exciting time for them and the whole agency. i think the future is here in terms of the culture change that's going on and we're working in many ways to institutionalize that and embed that in the practices of the agency. >> wouldn't it be fair -- i recognized when i asked that question, it may sound as if you're trying to take care of business or farmers, but isn't the reality that we end up with a safer food supply system when this is the attitude? >> you know, what we know
but equally important for your purpose, the people at fda embrace this wholeheartedly. the people who are at the front line in our agency are public health people, you know, enforcement is a tool, and that's been the culture of the agency given the statute we've had and the framework for food safety which has basically been an enforcement and statute oriented organization. on the front line people love that. they would much rather be getting good food safety outcomes and doing public health...
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Sep 7, 2015
09/15
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CSPAN2
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eye 59
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evidence is probably going to be different and a little lower than that of an administrator at the fda only hard-core researcher. i'm guessing one of those two is right, the administrator at fda, his or her job is to protect the public so the job is going to be to ask for the highest possible level of evidence. if you're that kid trying to struggle through chemotherapy, or if you're a hairdresser naked cdc oil for your kid with intractable seizures, or a guy who is suffering through ptsd like somebody i met when it's researching "stoned," been through a dozen different medications, a couple suicide attempts, needed some form of relief, your level of evidence, the threshold for what constitutes enough evidence will be different. not trying to privilege one of those positions but when i hear people arguing about whether there's enough evidence, often was going on his people know exactly much evidence there is but they just have a different tug boat for what constitutes enough evidence. made me think about that going forward as we enter the debate phase of this evening and it used to pars
evidence is probably going to be different and a little lower than that of an administrator at the fda only hard-core researcher. i'm guessing one of those two is right, the administrator at fda, his or her job is to protect the public so the job is going to be to ask for the highest possible level of evidence. if you're that kid trying to struggle through chemotherapy, or if you're a hairdresser naked cdc oil for your kid with intractable seizures, or a guy who is suffering through ptsd like...
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Sep 27, 2015
09/15
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CSPAN2
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eye 57
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he worried it would cause polio and all major medical decision makers fda ama and cdc turned against him. by 1968 no one made that salk back seat in the united states anymore. so he spends the rest of his life tried to get the vaccine licensed because in fact, people did get polio. it was a small number the scientific community was behind them so salk became tenacious to reverse that decision. that is where the rivalry really started to heat up but salk never set a bad word about say bin. >> but he was bombastic of very well-known in the scientific community very well respected and gave a lot of grief to salk. >> of the overside. >> there were not too many on salk side they're all on the side of sabin. >> but sabin made some big mistakes as well with his own research. have a wooded uss the value of the vaccine today that which was are in current use? >> it has an interesting history as time went on salk worked with the company in france to make a better new were version killed vaccine virus said that actually actually, the sabin vaccine it was taken off but that was four years after
he worried it would cause polio and all major medical decision makers fda ama and cdc turned against him. by 1968 no one made that salk back seat in the united states anymore. so he spends the rest of his life tried to get the vaccine licensed because in fact, people did get polio. it was a small number the scientific community was behind them so salk became tenacious to reverse that decision. that is where the rivalry really started to heat up but salk never set a bad word about say bin....
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Sep 13, 2015
09/15
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WJLA
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lyrica is fda-approved to treat this pain.cause serious allergic reactions or suicidal thoughts or actions. tell your doctor right away if you have these, new, or worsening depression, or unusual changes in mood or behavior. or swelling, trouble breathing, rash, hives, blisters, muscle pain with fever, tired feeling, or blurry vision. common side effects are dizziness, sleepiness, weight gain and swelling of hands, legs and feet. don't drink alcohol while taking lyrica. don't drive or use machinery until you know how lyrica affects you. those who have had a drug or alcohol problem may be more likely to misuse lyrica. now i have less diabetic nerve pain. and my biggest reason to walk... ...calls me grandpa. ask your doctor about lyrica. r minor arthritis pain. plus, just two aleve can last all day. you'd need 6 lenol arthritis to do that. aleve. all day strong. >>> finally tonight, it's one of the most revealing side effects of chemo therapy, losing hair. but here's john donvan with a new treatment, giving patients a fighting e
lyrica is fda-approved to treat this pain.cause serious allergic reactions or suicidal thoughts or actions. tell your doctor right away if you have these, new, or worsening depression, or unusual changes in mood or behavior. or swelling, trouble breathing, rash, hives, blisters, muscle pain with fever, tired feeling, or blurry vision. common side effects are dizziness, sleepiness, weight gain and swelling of hands, legs and feet. don't drink alcohol while taking lyrica. don't drive or use...
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Sep 11, 2015
09/15
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KGO
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what one official says is the fda's biggest change in more than 100 >>> the fbi is offering a big reward. the bureau is joining forces with the oakland police department to find cornell barnard joins us live. >> reporter: this was the last place visited before his murder in 2013, the sports facility on the cal campus. tonight his family encouraged that new crime fighters are on the unsolved case. >> i want nothing more than giving him the justice he deserves. >> reporter: renewing her plea to find her son's killer. now the fbi is standing with her. it is joining forces with the oakland police department to solve the cold case killing. >> our effort to help solve this case is a part of a broader fbi strategy and collaboration with the oakland police department with the goal of targeting the most violent crime in the city of oakland. >> reporter: the fbi now offering a $25,000 reward which can be seen on its website and a digital billboard on interstate 880. all information leading to the arrest of two suspects who shot him the night of june 12, 2013 after a minor fender bender in oakland.
what one official says is the fda's biggest change in more than 100 >>> the fbi is offering a big reward. the bureau is joining forces with the oakland police department to find cornell barnard joins us live. >> reporter: this was the last place visited before his murder in 2013, the sports facility on the cal campus. tonight his family encouraged that new crime fighters are on the unsolved case. >> i want nothing more than giving him the justice he deserves. >>...
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Sep 25, 2015
09/15
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KGO
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eye 108
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today, the fda is now considered the fastest regulatory agency in the world.dy approvals right-hand turn helping patients with medical needs and aren't any improvement over what's on the market. that's including two studies. >>> scientists say americans are eating later and that is contributing to weight gain. exercise may help kids deal with bullying. a great deal of research points to the fiez kal and psychological benefits of exercise. it can also help prevent the more psychological damages of bullying setting in. it also helps kids find friends and avoid bullying in the first place. >> mcdonalds, germany is debuting the company's first entirely antibiotic-free burger called the mcbee. and it's only available in europe at the moment. >> only in europe? >> i hope so. time now for ask me, our favorite segment. >> what kind of id do you need to give a change of address? >> this is a big identity theft crime. if you show up in person, they're going to ask for id and make sure they identify you. but you can also change it on line. so what do they do there? they
today, the fda is now considered the fastest regulatory agency in the world.dy approvals right-hand turn helping patients with medical needs and aren't any improvement over what's on the market. that's including two studies. >>> scientists say americans are eating later and that is contributing to weight gain. exercise may help kids deal with bullying. a great deal of research points to the fiez kal and psychological benefits of exercise. it can also help prevent the more psychological...
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Sep 4, 2015
09/15
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WCAU
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eye 76
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. >> the fda -- >> the fda steps in if there's a problem identified with with a product. unlike pharmaceuticals, they don't have to get approval prior. the only way the fda can step in is once harm is done. >> have we seen cases where some of the supplements have led to problems in children? >> we absolutely have. we've had cases of lead poisoning. we've had children die of infections because they're contaminated with bacteria and fungus. some of them contain pharmaceuticals, as well. they're dangerous products out there. >> this is scary. we're running short on time. what should parents be looking for? >> what parents can do is try to make sure that what they're purchasing is what the label states it is. if you look on the label. you see a verified sale. it's a 200-year-old institution. it tests all of the standards for pharmaceuticals and food additives. if it carries that seal, you can be sure that it what's on the label is in the battle. >> c.h.o.p. has been on the forefront educating parents about the dangers. and i know that parents appreciate the work you are doing
. >> the fda -- >> the fda steps in if there's a problem identified with with a product. unlike pharmaceuticals, they don't have to get approval prior. the only way the fda can step in is once harm is done. >> have we seen cases where some of the supplements have led to problems in children? >> we absolutely have. we've had cases of lead poisoning. we've had children die of infections because they're contaminated with bacteria and fungus. some of them contain...
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Sep 2, 2015
09/15
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WABC
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why the fda is saying you should take it with caution. >> first let's check in with jimmy kimmel to see who's on the show tonight. >> tonight salma hayack and [muted singing throughout] these girls have waited 62 days for this concert tonight. so far i've counted 32 omgs, 75 lols, 13 yolos, and i'm super tired! tweens--fun age, huh? you have places to go. [girls squealing with delight] let us worry about getting you there. bp gasoline with invigorate. fuel the journey. (gong) marinate your steak with kikkoman to enhance its juicy, natural essence. (taiko drum beat) (taiko drum beat) >>> new video tonight gives a good look at the newest edition to the national zoo in washington, d.c. giant panda mei xiang put her cub down last night and left the den briefly, allowing cameras streaming live to the internet capture the images showing the male cub is healthy and its characteristic black markings are developing nicely. >>> a new warning about powdered caffeine. the fda issuing warning letters to five distributors of the stimulant saying their product put customers at risk. it says the differ
why the fda is saying you should take it with caution. >> first let's check in with jimmy kimmel to see who's on the show tonight. >> tonight salma hayack and [muted singing throughout] these girls have waited 62 days for this concert tonight. so far i've counted 32 omgs, 75 lols, 13 yolos, and i'm super tired! tweens--fun age, huh? you have places to go. [girls squealing with delight] let us worry about getting you there. bp gasoline with invigorate. fuel the journey. (gong)...
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Sep 2, 2015
09/15
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WABC
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the fda says it's very easy to overdose. the letters follow the overdose deaths last year of two young men. consumer advocacy groups want them banned. >>> you can soon get breakfast all day at mc. as of october 6th the chain is doing away with the midmorning cutoff. operators voted in favor of the move. they were testing in markets for months. we're hoping hashbrowns and the egg mcmuffin will. >> big news. no more kicking rocks all the way back to the parking lot after saying no. >>> when we come back, on alert. four random cars hit with gunfire on an interstate. a possible sniper on the loose. >>> dodger dreams. why this man spent more than two weeks sleeping outside a stadium. embrace your face. embrace your face with covergirl makeup. there's a finish, a shade and a formula for every face out there. clean oil control shine-free and fresh. trublend flawlessly blendable. simply ageless age-defying, full coverage. embrace your covergirl face try the award-winning foundation lines of easy breezy beautiful covergirl. now find
the fda says it's very easy to overdose. the letters follow the overdose deaths last year of two young men. consumer advocacy groups want them banned. >>> you can soon get breakfast all day at mc. as of october 6th the chain is doing away with the midmorning cutoff. operators voted in favor of the move. they were testing in markets for months. we're hoping hashbrowns and the egg mcmuffin will. >> big news. no more kicking rocks all the way back to the parking lot after saying no....
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354
Sep 2, 2015
09/15
by
WABC
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why the fda is saying you should take it with caution. >> first let's check in with jimmy kimmel to see who's on the show tonight. >> tonight salma hayack and >>> new video tonight gives a good look at the newest edition to the national zoo in washington, d.c. giant panda mei xiang put her cub down last night and left the den briefly, allowing cameras streaming live to the internet capture the images showing the male cub is healthy and its characteristic black markings are developing nicely. >>> a new warning about powdered caffeine. the fda issuing warning letters to five distributors of the stimulant saying their product put customers at risk. it says the difference between a safe amount and toxic amount is very small. two people died last year after consuming it. one company will take its powdered caffeine completely off the market. >>> rob powers up next with sports. >> talking tennis. hot and steamy night at the national tennis center. plenty of baseball to talk about as well. mets fight the phillies one more time. this time the phils fight back. the yankees in boston trying their
why the fda is saying you should take it with caution. >> first let's check in with jimmy kimmel to see who's on the show tonight. >> tonight salma hayack and >>> new video tonight gives a good look at the newest edition to the national zoo in washington, d.c. giant panda mei xiang put her cub down last night and left the den briefly, allowing cameras streaming live to the internet capture the images showing the male cub is healthy and its characteristic black markings are...
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as of today the device is now available for purchase after receiving clearance by the fda.the tubing of a traditional stethoscope doctors can take digital recordings of patient heart beats. the recording will be transmitted to a computer. the device retails for $199. tonight at 6:00 reporter jonathan blum will introduce you to the student behind the smart stethoscope. >>> an oakland based nonprofit is taking legal action against inventor of e-cigarette makers. the finding came from a study conducted that tested products from 24 companies. the nonprofit says the findings are in violation of state standards. >>> most americans hearts are older than they are and the fda is issuing an order. >> jane king has those stories and more. >> your heart may be older than you are. that's not good according to a new cdc vital signs report. a predicted heart age is older than their actual age meaning higher risk for heart attacks and strokes. heart age is the age of the cardiovascular system based on risk factor profile including high blood pressure, cigarette smoking and diabetes and bmi
as of today the device is now available for purchase after receiving clearance by the fda.the tubing of a traditional stethoscope doctors can take digital recordings of patient heart beats. the recording will be transmitted to a computer. the device retails for $199. tonight at 6:00 reporter jonathan blum will introduce you to the student behind the smart stethoscope. >>> an oakland based nonprofit is taking legal action against inventor of e-cigarette makers. the finding came from a...