Updates Dr. Hahn's Remarks to FDA's Disability Awareness Roundtable - 10/29/2020  | | Stephen M. Hahn, M.D., Commissioner of Food and Drugs FDA staff joined Commissioner Dr. Hahn on Thursday to celebrate National Disability Employment Awareness Month. We recognize America's workers with disabilities and the importance of policies that support inclusiveness in the workplace. | Consumer Updates Treating and Preventing Head Lice
Head lice are most common among preschool children attending child care, elementary school children, and household members of children who have head lice. While lice are a year-round problem, the number of cases seems to peak when the kids go back to school in the fall and again in January, says Patricia Brown, M.D., a dermatologist at the Food and Drug Administration (FDA). Contrary to myth, head lice are not caused by poor hygiene, Brown says. They are spread mainly by direct head-to-head contact with a person who already has head lice. You cannot get head lice from your pets; lice feed only on humans. [10/27/2020] FDA Insight Join Dr. Anand Shah, FDA's Deputy Commissioner for Medical and Scientific Affairs, and other FDA leaders as they provide their insight into issues facing the agency – including the COVID-19 pandemic and other emerging topics.  | | FDA Insight: Get Your Flu Vaccine On this week's episode, Dr. Shah brings Dr. Peter Marks back to the show to discuss the importance of getting the flu vaccine. For more information about the flu vaccine click here. [10/27/2020] | Guidance Documents - Request for Comment Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products
This guidance provides sponsors with recommendations on the nonclinical information to support development and approval of orally inhaled nicotine-containing drug products, including electronic nicotine delivery systems intended for smoking cessation and related chronic indications. Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date
FDA is issuing this guidance to revise its compliance policy regarding the deadline for filing premarket approval (PMA) applications for previously cleared accessories necessary to the operation of automated external defibrillator (AED)1 systems. This policy is based, in part, in consideration of the burden on healthcare facilities as they transition to FDA-approved AEDs and on the manufacturers as they prepare to implement the PMA requirements while addressing the challenges related to Coronavirus Disease 2019 (COVID-19). ICYMI! (In Case You Missed It!) Advisory Committees Give FDA Critical Advice and the Public a Voice  At the U.S. Food and Drug Administration, we rely on our many advisory committees to help us make sound decisions based on the best science available. The FDA's complex and multifaceted mission includes evaluating new medicines, including vaccines and other therapies, to determine if they are safe and effective for their intended use. FDA advisory committees give our own agency experts outside, independent, and professional advice on various complex scientific, technical, and policy issues. Webinars and Virtual Workshops Public Meeting on the Reauthorization of the Biosimilar User Fee Act (BsUFA)
The FDA is announcing a public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2023 through 2027. BsUFA authorizes FDA to collect user fees to support the process of review of biosimilar biological products. The current legislative authority for BsUFA expires in September 2022. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. FDA begins the BsUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. November 19, 2020; 9:00 AM - 12:30 PM ET
Please register here. Scientific Conference: CBD and Other Cannabinoids: Sex and Gender Differences in Use and Responses
The FDA Office of Women's Health is hosting a public meeting to discuss potential sex (biological) and gender (psychosocial) differences in use and responses to cannabidiol (CBD) and other cannabinoids. Researchers, educators, clinicians, and patients may benefit from attending this multidisciplinary scientific conference on CBD and other cannabinoids. Presentations will address patient and healthcare provider perspectives on CBD and other cannabinoid use, sex differences in the effects of CBD and other cannabinoids, use of CBD and other cannabinoids in pregnancy, and government agency perspectives on CBD research and evaluation. November 19, 2020; 9:00 AM - 4:00 PM ET Please register here. Office of Prescription Drug Promotion - Core Launch Review Process
This webinar will provide an overview of the upcoming changes to the Office of Prescription Drug Promotion's (OPDP) Core Launch Review process. The updates to the Core Launch Review process are designed to improve efficiencies, maximize use of FDA's resources, provide timely feedback to firms, and support our mission to help ensure prescription drug promotion is truthful, balanced, and accurately communicated. November 20, 2020; 1:00 PM - 2:00 PM ET Please register here. SEND for CBER, What You Need to Know
This webinar is to discuss Center for Biologics Evaluation and Research's (CBER's) support and requirement for the Standard for the Exchange of Nonclinical Data (SEND), which was published in the Federal Register on July 14, 2020, and the addition of SEND for CBER to the FDA Data Standards Catalog. FDA will discuss the background of the new requirement and how SEND will aid CBER reviewers. December 4, 2020; 1:00 PM - 2:00 PM ET Please register here. Drug Supply Chain Security Act pilot project program and enhanced drug distribution security FDA will host a virtual public meeting to provide members of the pharmaceutical distribution supply chain and other stakeholders an opportunity to provide input on strategies and issues related to enhanced drug distribution security and discuss results from FDA's DSCSA pilot project program. December 8-9, 2020; 9:00 AM - 4:00 PM ET Please request registration here. About Us The FDA Stakeholder Engagement Staff reside within the Office of the Commissioner and support the FDA mission by engaging with Patient and Health Professional Organizations, Consumer Groups, Trade Associations, Think Tanks and other external stakeholders. We encourage and support active engagement from external stakeholders related to policy that impacts human and animal medical products, cosmetics, tobacco, nutrition and food safety that promote health and healthy living. | 
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