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Mar 14, 2014
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dr. hamburg. >> thank you, mr. chairman. dr. hamburg, thank you for being here and thanks for your service. i'm sure you're probably aware, skin cancers reaching epidemic proportions in the united states. in fact, one person and our dies now for melanoma, not to mention disfigurement of squamous cell and basal scale and other skin cancer but it's been since 1990 was the last time the fda approved an application for an enhanced ingredient for sunscreen capability at are some applications that of impending longer than a decade for action. senator reid, democratic cosponsor and this off, and you're familiar with the think some of the initials -- initiatives were taken, will introduce legislation to make more transparent and more rapid determination in terms of skin care ingredients and products. we don't want in any way legislate what fda should approve, but we want to get a more transparent and a more effective system of evaluating these important ingredients for this terrible cancer. would you commit to work with our offices augus
dr. hamburg. >> thank you, mr. chairman. dr. hamburg, thank you for being here and thanks for your service. i'm sure you're probably aware, skin cancers reaching epidemic proportions in the united states. in fact, one person and our dies now for melanoma, not to mention disfigurement of squamous cell and basal scale and other skin cancer but it's been since 1990 was the last time the fda approved an application for an enhanced ingredient for sunscreen capability at are some applications...
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Mar 15, 2014
03/14
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dr. hamburg, for working with us so closely on that. thatur testimony you noted your quick interpretation of the law is allowing companies to register is outsourcing facilities already. this was a critical component of our bill. can you tell the committee why this is so important? how does this new option improve public health and prevent a new outbreak? at high-riskrgeted products. injectables that we know can ontaminated and when they do they have serious consequences for health. enable, for those companies that choose to register with us, a higher level of assurance in terms of good manufacturing practice and oference with the kinds manufacturing procedures that need to be undertaken to make these products safe. we think that this is hugely important. as a mentioned earlier, we that companies will choose to go this pathway and hopefully the marketplace will view this as appropriate standard of care for the health, safety, and protection of their patients in the health care system. hopefully they will seek them out not just to registe
dr. hamburg, for working with us so closely on that. thatur testimony you noted your quick interpretation of the law is allowing companies to register is outsourcing facilities already. this was a critical component of our bill. can you tell the committee why this is so important? how does this new option improve public health and prevent a new outbreak? at high-riskrgeted products. injectables that we know can ontaminated and when they do they have serious consequences for health. enable, for...
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Mar 14, 2014
03/14
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dr. hamburg thank you for being here. so what is reaching epidemic proportions one person got melanoma and not to mention in squamous cell m basil's guilt -- so skin cancer 1990 was the last time the fda applied one dash approved for the enhanced ingredient for sunscreen capability and some applications have been pending more than a decade. can you are familiar with those initials and trying to make more transparent and determination with skin-care ingredients we don't want to legislate what the fda should approve but a more transparent and effective system to evaluate these ingredients for this cancer. would you agree to work with our office to get a more rapid response? >> absolutely. it has been taking too long. we are eager to work with you on the decision we are moving forward with our evaluation of sunscreen additives getting back to sponsors on our assessment and we're looking if we can modernize the overall framework how these over-the-counter products submit applications to streamline and make it more responsive
dr. hamburg thank you for being here. so what is reaching epidemic proportions one person got melanoma and not to mention in squamous cell m basil's guilt -- so skin cancer 1990 was the last time the fda applied one dash approved for the enhanced ingredient for sunscreen capability and some applications have been pending more than a decade. can you are familiar with those initials and trying to make more transparent and determination with skin-care ingredients we don't want to legislate what...
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Mar 15, 2014
03/14
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dr. hamburg, for working with us so closely on that. in your testimony you noted your quick implementation of the laws to register as outsourcing facilities, what we call outsourcing facilities already, this is a component of our bill. can you tell the committee while this was so important, how does this new option improve public health and prevent new outbreaks. >> this is targeted on high risk products, injecteds that we know can become contaminated and have very serious consequences for health. this will enable those companies that choose to register with us a higher level of assurance in terms of good manufacturing practice and adherence with the kind of manufacturing procedures that need to be undertaken to make these products safe. so we think this is a hugely important as i mentioned earlier. we certainly hope this company will choose to go this path way and importantly the marketplace will view this as an appropriate standard of care for the health, safety and protection of patients and health care systems will seek out those th
dr. hamburg, for working with us so closely on that. in your testimony you noted your quick implementation of the laws to register as outsourcing facilities, what we call outsourcing facilities already, this is a component of our bill. can you tell the committee while this was so important, how does this new option improve public health and prevent new outbreaks. >> this is targeted on high risk products, injecteds that we know can become contaminated and have very serious consequences...
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Mar 1, 2014
03/14
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dr. peggy hamburg. she has a passion for food safety and food issues and an important newport folio and is here to talk more in detail about the proposed changes to the nutrition facts label. dr. hamburg. >> thank you so much, secretary sebelius. i'm delighted to be joining all of you for today's let's move announcement in which f.d.a.'s unveiling our proposed changes to a new and improved, more user friendly version of the nutrition facts label. before i walkthrough our proposed changes, i also want to join secretary sebelius and thank first lady michelle obama for her continued commitment to encourage americans to live healthier lifestyles and recognize the four-year anniversary of the let's move initiative. for 20 years we have relied on the now iconic nutrition facts label to help us make informed food choices on what to eat. when it was first introduced this landmark label provided the american consumer for the first time with the uniform information about the nutritional content of the foods. sinc
dr. peggy hamburg. she has a passion for food safety and food issues and an important newport folio and is here to talk more in detail about the proposed changes to the nutrition facts label. dr. hamburg. >> thank you so much, secretary sebelius. i'm delighted to be joining all of you for today's let's move announcement in which f.d.a.'s unveiling our proposed changes to a new and improved, more user friendly version of the nutrition facts label. before i walkthrough our proposed changes,...
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Mar 15, 2014
03/14
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dr. hamburg, thank you for being here today. we look forward to visiting with you. i'm going to devote most of my attention to the drug quality and security act, which was signed into law last fall to clarify fda authority over compounding pharmacies. that's very important to many states, but especially to tennessee. the fungal meningitis outbreak in 2012 was a nightmare for us. 130 seven tennesseans became sick. 16 others died from the outbreak. it's caused by contaminated steroid injections. while the final legislation, the law, was not a strong is the bill that passed this committee, it does make it clear that either the fda or the state is overseeing each compounding facility. compounding sterile drugs without prescriptions now have the ability to voluntarily register with the fda as outsourcing facilities. committing to higher standards for sterile compounded drugs to report adverse events put on certain labels and lift the product they make with the fda. the legislation, the new law cap state oversight of traditional drugstore, the corner and fda oversight ove
dr. hamburg, thank you for being here today. we look forward to visiting with you. i'm going to devote most of my attention to the drug quality and security act, which was signed into law last fall to clarify fda authority over compounding pharmacies. that's very important to many states, but especially to tennessee. the fungal meningitis outbreak in 2012 was a nightmare for us. 130 seven tennesseans became sick. 16 others died from the outbreak. it's caused by contaminated steroid injections....
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Mar 19, 2014
03/14
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dr. hamburg here and others to fully debate this as we continue.hank you very much, senator. >> thank you, andrea, appreciate it. >>> bob menendez joins me next for the latest on the situation in crimea and the rest of ukraine. ♪ [ male announcer ] you're watching one of the biggest financial services companies in the country at work. hey. thanks for coming over. hey. [ male announcer ] how did it come to be? yours? ah. not anymore. it's a very short story. come on in. [ male announcer ] by meeting you more than halfway. it's how edward jones makes sense of investing. don't worry! the united states postal service will get it there on time with priority mail flat rate shipping. ♪ whoo-hoo! ♪ [ male announcer ] our priority has always been saving the day. because our priority... amazing! [ male announcer ] ...is you! the amazing spider-man 2 delivered by the united states postal service. plays a key role throughout our lives. one a day men's 50+ is a complete multivitamin designed for men's health concerns as we age. with 7 antioxidants to support ce
dr. hamburg here and others to fully debate this as we continue.hank you very much, senator. >> thank you, andrea, appreciate it. >>> bob menendez joins me next for the latest on the situation in crimea and the rest of ukraine. ♪ [ male announcer ] you're watching one of the biggest financial services companies in the country at work. hey. thanks for coming over. hey. [ male announcer ] how did it come to be? yours? ah. not anymore. it's a very short story. come on in. [ male...