FDA Stakeholder Update - September 10, 2021

September 10, 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 September 9, 2021 - FDA Makes Significant Progress in Science-Based Public Health Application Review, Taking Action on Over 90% of More Than 6.5 Million 'Deemed' New Tobacco Products Submitted September 9, 2021 - FDA, FTC Warn 10 Companies Illegally Selling Dietary Supplements Claiming to Treat Diabetes September 9, 2021 - FDA In Brief: As Consumers Order More Meals and Groceries Online, FDA Plans Public Meeting to Address Food Safety Risks September 8, 2021 - FDA In Brief: FDA Announces Public Workshop to Reconsider Mandatory Prescriber Education for Opioids September 7, 2021 - Coronavirus (COVID-19) Update Consumer Updates Why You Should Not Use Ivermectin to Treat or Prevent COVID-19 COVID-19. We've been living with it for what sometimes seems like forever. Given the number of deaths that have occurred from the disease, it's perhaps not surprising that some consumers are turning to drugs not approved or authorized by the Food and Drug Administration (FDA).  One of the FDA's jobs is to carefully evaluate the scientific data on a drug to be sure that it is both safe and effective for a particular use. In some instances, it can be highly dangerous to use a medicine for the prevention or treatment of COVID-19 that has not been approved by or has not received emergency use authorization from the FDA.  Read More Learn More About COVID-19 Vaccines From the FDA The U.S. Food and Drug Administration approved Comirnaty for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. The vaccine has the same formulation as the Pfizer-BioNTech COVID-19 Vaccine that continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age, and for the administration of a third dose in certain immunocompromised individuals. Read More Webinars and Virtual Workshops 2021 Compounding Quality Center of Excellence Virtual Conference: Culture of Quality The virtual conference will bring together outsourcing facilities, regulators and industry leadership to engage on emerging industry topics and best practices to improve the overall quality of compounded drugs, focusing on a culture of quality. An optional pre-conference session geared toward first time attendees will be held on September 13, 2021. September 14 - 15, 2021 Day 1: September 14, 2021; 11:00 AM - 5:35 PM ET Day 2: September 15, 2021; 11:00 AM - 5:15 PM ET Registration is tentative until approved. Conference registration is free and includes access to an interactive platform as well as live sessions and presentations. Early registration is recommended. Register Here Conversation on Cancer: "The Future of Childhood Cancer Drug Development: Is the Sky the Limit?" The FDA Oncology Center of Excellence presents Conversations on Cancer - The Future of Childhood Cancer Drug Development: Is the Sky the Limit? Join this 1 ½ hour informal panel discussion exploring personal perspectives from survivors, clinicians, caregivers, and pediatric patient advocates on the impact of childhood cancer.  September 16, 2021; 1:00 PM - 2:30 PM ET Register Here Public Meeting on the Recommendations for Prescription Drug User Fee Act (PDUFA) Reauthorization The FDA is announcing a virtual public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2023 through 2027. September 28, 2021; 9:00 AM - 2:00 PM ET Register Here 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. 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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