Dear Colleague,
FDA’s Stakeholders Engagement Team continuously works to provide you with up-to-date information that helps to further our commitment in advancing public health and well-being. A few notable items were issued this week, including:
FDA’s Stakeholders Engagement Team continuously works to provide you with up-to-date information that helps to further our commitment in advancing public health and well-being. A few notable items were issued this week, including:
FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on the FDA’s continuing efforts to maintain its strong oversight of generic drug quality issues domestically and abroad - At the FDA, protecting patient and consumer health is our highest priority. Assessing and mitigating risks is at the heart of everything we do across our vast portfolio. Sometimes the actions we take are visible, like warning letters or recalls. At other times, our actions to protect consumers are less discernible, but equally vital. Analyzing and addressing potential risks is a complex effort based on data and grounded in science. (February 22, 2019)
FDA Commissioner Scott Gottlieb, M.D., on efforts to spur development of innovative devices, including new advancements in novel brain implants, that can help patients with paralysis or amputation gain mobility - Advances in technology and material science are enabling new opportunities to transform health and mobility through innovations in medical products. The FDA is committed to adopting pathways that allow patients efficient access to these safe and effective products. (February 22, 2019)
The FDA's Oncology Center of Excellence — Quantifying the Patient Experience - The Patient-Focused Drug Development Program fosters collaboration between FDA Centers and external stakeholders involved in patient outcomes research in cancer populations.The overarching goal of the program is to identify rigorous methods to assess the patient experience that will complement existing survival and tumor information to better inform a cancer therapy’s effect on the patient. (February 22, 2019)
FDA advances new proposed regulation to make sure that sunscreens are safe and effective - FDA issued a proposed rule that would update regulatory requirements for most sunscreen products in the United States. This significant action is aimed at bringing nonprescription, over-the-counter (OTC) sunscreens that are marketed without FDA-approved applications up to date with the latest science to better ensure consumers have access to safe and effective preventative sun care options. Consumer Update (February 21, 2019)
FDA Commissioner Scott Gottlieb, M.D., on additional steps by the agency to support the development of safe and effective novel nicotine replacement therapies to help smokers quit cigarettes - More than 54 years after the landmark Surgeon General’s report on smoking and health, tobacco use – primarily cigarette smoking – remains the leading cause of preventable disease and death in the U.S., responsible for 480,000 premature deaths each year. Why? Because cigarettes are incredibly addictive. While nicotine keeps smokers addicted, it’s the smoke and the 7,000 chemicals contained in it that causes the disease and death. That’s why a key element of our comprehensive plan to significantly reduce tobacco-related disease and death is recognizing that nicotine, while highly addictive, is delivered through products along a continuum of risk with combustible cigarettes at one end, and nicotine replacement therapy (NRT) products at the other. (February 21, 2019)
FDA advances framework for enabling the study of new tobacco products - FDA issued a revised draft guidance, “Use of Investigational Tobacco Products,” intended to assist tobacco product manufacturers, academic institutions and institutional review boards studying tobacco products. Among other things, it outlines the kind of information the agency intends to consider in making enforcement decisions regarding the use of investigational tobacco products, including potential human subject protection concerns or other impacts on public health. (February 20, 2019)
FDA Commissioner Scott Gottlieb, M.D., on efforts to spur development of innovative devices, including new advancements in novel brain implants, that can help patients with paralysis or amputation gain mobility - Advances in technology and material science are enabling new opportunities to transform health and mobility through innovations in medical products. The FDA is committed to adopting pathways that allow patients efficient access to these safe and effective products. (February 22, 2019)
The FDA's Oncology Center of Excellence — Quantifying the Patient Experience - The Patient-Focused Drug Development Program fosters collaboration between FDA Centers and external stakeholders involved in patient outcomes research in cancer populations.The overarching goal of the program is to identify rigorous methods to assess the patient experience that will complement existing survival and tumor information to better inform a cancer therapy’s effect on the patient. (February 22, 2019)
FDA advances new proposed regulation to make sure that sunscreens are safe and effective - FDA issued a proposed rule that would update regulatory requirements for most sunscreen products in the United States. This significant action is aimed at bringing nonprescription, over-the-counter (OTC) sunscreens that are marketed without FDA-approved applications up to date with the latest science to better ensure consumers have access to safe and effective preventative sun care options. Consumer Update (February 21, 2019)
FDA Commissioner Scott Gottlieb, M.D., on additional steps by the agency to support the development of safe and effective novel nicotine replacement therapies to help smokers quit cigarettes - More than 54 years after the landmark Surgeon General’s report on smoking and health, tobacco use – primarily cigarette smoking – remains the leading cause of preventable disease and death in the U.S., responsible for 480,000 premature deaths each year. Why? Because cigarettes are incredibly addictive. While nicotine keeps smokers addicted, it’s the smoke and the 7,000 chemicals contained in it that causes the disease and death. That’s why a key element of our comprehensive plan to significantly reduce tobacco-related disease and death is recognizing that nicotine, while highly addictive, is delivered through products along a continuum of risk with combustible cigarettes at one end, and nicotine replacement therapy (NRT) products at the other. (February 21, 2019)
FDA advances framework for enabling the study of new tobacco products - FDA issued a revised draft guidance, “Use of Investigational Tobacco Products,” intended to assist tobacco product manufacturers, academic institutions and institutional review boards studying tobacco products. Among other things, it outlines the kind of information the agency intends to consider in making enforcement decisions regarding the use of investigational tobacco products, including potential human subject protection concerns or other impacts on public health. (February 20, 2019)
If you have any questions please feel free to contact our office FDAStakeholderEngagementTeam@
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