FDA Stakeholder Update - October 1, 2021

If your email program has trouble displaying this email, view as a webpage. October 1, 2021 Dear Colleague, As you and other public health advocates work on the front lines of the COVID-19 pandemic, we want you to know that we recognize your concerns about protecting the safety of yourselves, your families, and others you care for. The FDA's work is critical to ensuring the health and safety of the American public at any time, but is magnified during public health emergencies. As we address the challenges of the COVID-19 pandemic, protecting the public's health, using science to guide our decisions, and facilitating access to critical medical products continue to be top priorities for the FDA. Stay up to date on Coronavirus Disease 2019 (COVID-19) by visiting the Resources for Health Professionals page. Updates October 1, 2021 - Coronavirus (COVID-19) Update October 1, 2021 - FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children September 30, 2021 - Youth E-cigarette Use Remains Serious Public Health Concern Amid COVID-19 Pandemic September 30, 2021 - FDA Clears First Major Imaging Device Advancement for Computed Tomography in Nearly a Decade September 29, 2021 - FDA In Brief: FDA Warns Consumers of Risk of Exposure to Unsafe Levels of Radiation with Safe-T-Lite UV WAND September 28, 2021 - Remarks by Acting Commissioner Janet Woodcock to the Public Meeting on the Recommendations for Prescription Drug User Fee Act (PDUFA) Reauthorization September 21, 2021 - FDA Response to the Fukushima Daiichi Nuclear Power Facility Incident Guidance Documents - Request for Comment Benefit-Risk Assessment for New Drug and Biological Products  The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about a drug's benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that the Food and Drug Administration (FDA or Agency) makes about new drug applications (NDAs) submitted under section 505(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as well as biologics license applications (BLAs) submitted under section 351(a) of the Public Health Service Act (PHS Act). Submit Comments Microbiological Quality Considerations in Non-Sterile Drug Manufacturing This guidance is intended to assist manufacturers in assuring the control of microbiological quality of their non-sterile drugs (NSDs). The recommendations herein apply to solid non-sterile dosage forms, as well as semi-solid, and liquid non-sterile dosage forms (e.g., topically applied creams, lotions and swabs, and oral solutions and suspensions). Submit Comments Consumer Updates Keep Lilies Away From Your Cats The white, trumpet-shaped Easter lily symbolizes Easter and spring for many people, and is a popular decoration in homes at this time of year. If you have cats, however, the Food and Drug Administration (FDA) wants to remind you that these particular flowers, as well as Tiger, Asiatic, Day, and Japanese Show lilies, are a safety threat to your feline friends. Read More It's a Good Time to Get Your Flu Vaccine While the U.S. remains focused on the COVID-19 pandemic, we need to also be aware of flu season as we approach winter. Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated now can lower your chances of getting the flu. Flu is a serious disease, caused by influenza viruses, that can lead to hospitalization and even death. Every flu season is different, and the substantial health impacts can vary widely from season to season, with some flu seasons being worse than others. Your best defense is vaccination, which provides protection from flu and its potential complications. Read More ICYMI! Stakeholder Call: Pfizer-BioNTech COVID-19 Vaccine Booster Dose  Acting FDA Commissioner, Janet Woodcock, M.D. and Director, FDA Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., discuss the Pfizer-BioNTech COVID-19 Vaccine Booster Dose.  YouTube Video Stakeholder Call: FDA Takes Steps Aimed at Improving Quality, Safety and Efficacy of Sunscreens Director, Office of Nonprescription Drugs, Center for Drug Evaluation and Research, Theresa Michele, M.D., discussed steps the Agency has taken, which are aimed at improving the quality, safety, and efficacy of sunscreens.  YouTube Video Webinars and Virtual Workshops 11th Annual Global Summit on Regulatory Science Regulatory Sciences for Food/Drug Safety with Real-World Data & Artificial Intelligence. Question & Answer Sessions. Opening remarks FDA Acting Commissioner, Janet Woodcock. Two keynote presentations by government-agency senior leadership from US and EU Platform presentations from scientists representing Brazil, Canada, EU, India, Italy, Japan, Singapore, Switzerland, and US. A live debate on the topic, "Is Regulatory Science Ready for AI?"  A special workshop to showcase data-science tools currently in regulatory use by FDA, European Medicines Agency (EMA), and Swissmedic. October 4 - 6, 2021; 8:00 AM - 11:00 AM ET Register Here Patient Engagement Advisory Committee Meeting Announcement During this meeting, the Patient Engagement Advisory Committee (the Committee) will discuss factors the FDA and industry should consider to effectively communicate medical device recall information to patients and the public, including but not limited to content, format, methods used to disseminate the message, and timing of communication. The Committee will consider concerns patients have about changes to their device in response to a recall and ways patient perspectives could be incorporated in the FDA's and industry's benefit-risk decision-making of recalled medical devices. October 6, 2021; 10:00 AM - 5:00 PM ET Registration is not required. Public Meeting on the Recommendations for Biosimilar User Fee Act (BsUFA) Reauthorization FDA will hold a virtual public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2023 through 2027 ("BsUFA III"). BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological product applications. November 2, 2021; 9:00 AM - 12:00 PM ET Register Here About Us The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations. Did someone forward you this email? Sign up below! Subscribe Here

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