FDA Stakeholder Update - February 19, 2021

February 19, 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 February 18, 2021 - COVID-19 Update: USDA, FDA Underscore Current Epidemiologic and Scientific Information Indicating No Transmission of COVID-19 Through Food or Food Packaging February 17, 2021 - FDA Approves First in the World, First-of-Its-Kind Implant for the Treatment of Rare Bone Disease as a Humanitarian Use Device February 16, 2021 - Coronavirus (COVID-19) Update Recommendations About the Use of Dental Amalgam in Certain Higher-Risk Groups The FDA has developed graphics that provide a visualization of recommendations about the use of dental amalgam (a mercury-containing dental restorative or filling material) in certain groups of people who may be at greater risk for potential harmful health effects of mercury exposure.  These higher-risk groups are: Pregnant women and their developing fetuses Women who are planning to become pregnant Nursing women and their newborns and infants Children, especially those younger than six People with preexisting neurological disease People with impaired kidney function People with known heightened sensitivity (allergy) to mercury or other components of dental amalgam. Get the Graphics Spotlight Black History Month This Black History Month, FDA ORA honors Alma Levant Hayden, who was among the first African-American female scientists. She is known for her role in a court case that identified the anti-cancer medication Krebiozen as creatine, a common amino acid found naturally in meat. FDA Voices Reflections on a Record Year for Novel Device Innovation Despite COVID-19 Challenges By: Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH) and William Maisel, M.D., MPH, Director, Office of Product Evaluation and Quality, CDRH As we look ahead this year, it is important to pause and reflect on the important milestones the FDA reached in 2020 to help strengthen the public health. Among those milestones is the work the FDA's Center for Devices and Radiological Health (CDRH) accomplished in response to the COVID-19 pandemic, while keeping up with the Center's ongoing work and continuing to bring a growing portfolio of innovative devices to patients. Most notably, the FDA approved, cleared, or authorized ("authorized") a record high of 132 novel medical devices in 2020, surpassing the 40-year high mark we set in 2018 and capping off 10 years of progress. It is a big leap from the 29 novel devices we authorized a decade ago, in 2010. [2/16/2021] ICYMI! FDA's Generic Drug Program in 2020 Helped Ensure Availability of High-Quality, Affordable Drugs Amid COVID-19 By: Sally Choe, Ph.D., Director, Office of Generic Drugs, Center for Drugs Evaluation and Research  Generic drugs play a vital role in facilitating access to lifesaving medicines for Americans and remain a public health priority for the FDA. Right now, there are more than 10,000 FDA-approved generic drugs and nine out of 10 prescriptions in the U.S. are filled by generics. Generic drugs have saved the health care system close to $2.2 trillion. [2/11/2021] Webinars and Virtual Workshops Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic The FDA will host a webinar on Updated Information on Respirator Decontamination Systems.This webinar is part of the series on Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use during the COVID-19 Pandemic. February 23, 2021; 12:00 PM - 1:00 PM ET  Registration is not required. Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation The FDA will host a virtual Town Hall for SARS-CoV-2 test developers. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. February 24, 2021; 12:15 PM - 1:15 PM ET Registration is not required. Vaccines and Related Biological Products Advisory Committee The committee will meet in open session to discuss EUA of the Janssen Biotech Inc. COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years and older. February 26, 2021; 9:00 AM - 5:30 PM ET Registration is not required. Drug Master File (DMF) and Drug Substance Workshop This conference is designed to provide an update on current Agency initiatives and will cover a wide variety of topics of interest to API manufacturers and regulators. Specifically, the Agency wishes to provide guidance on the DMF submission process and expectations for content through a series of presentations, panel discussions, and Q&A for two poster sessions. March 3 - 4, 2021; 7:30 AM - 4:30 PM ET Register for this event here. Public Meeting: FDA Rare Disease Day 2021 The purpose of this meeting is to highlight strategies to support rare disease product development. Patients, patient advocates, researchers, and medical product developers may benefit from attending this public meeting on rare disease product development. March 5, 2021; 9:00 AM - 4:00 PM ET Register for this event here. Public Meeting on Patient-Focused Drug Development for Vitiligo FDA is hosting a virtual public meeting on Patient-Focused Drug Development for Vitiligo. FDA is interested in hearing patients' perspectives on the impact of vitiligo on daily life and patient views on treatment approaches. March 8, 2021; 10:00 AM - 2:30 PM ET Register for this event here. Precisely Practicing Medicine for COVID, from a Half Million Tested Patients and a Trillion Points of Data Dr. Butte, a computer scientist and pediatrician, will highlight his center's recent work on integrating electronic health records data across the entire University of California, and how analytics on this "real world data" can lead to new evidence for drug efficacy, new savings from better medication choices, and new methods to teach intelligence – real and artificial – to more precisely practice medicine, especially during this era of COVID-19. March 10, 2021; 3:00 PM - 4:00 PM ET Registration is not required. 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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