FDA Stakeholder Update - June 19, 2020

Dear Colleague,

As you and other health care providers work on the front lines of the COVID-19 pandemic, we want you to know we are here to help you and your patients through this critical time. We recognize your concerns about protecting the safety of your patients, yourselves, and your families.

While our nation’s emphasis is on combatting the virus, protecting health care providers and facilitating access to critical medical supplies continue to be a top priority for the FDA.

Updates June 18, 2020 - Daily Roundup June 18, 2020 - Visit our “At-A-Glance” resource summarizing the FDA COVID-19 Response June 18, 2020 - FDA Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts June 17, 2020 - Daily Roundup June 17, 2020 - FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk June 16, 2020 - Daily Roundup June 16, 2020 - Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling June 16, 2020 - FDA Revokes Emergency Use Authorization for Chembio Antibody Test June 16, 2020 - FDA Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic June 15, 2020 - FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD June 15, 2020 - FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of a COVID-19 Treatment Authorized for Emergency Use Stay up to date on Coronavirus Disease 2019 (COVID-19) by visiting the Resources for Health Professionals page. Resources for HP Request for Comments Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry: This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices. Submit Comments For a more comprehensive list of all official FDA Guidance Documents and other regulatory guidances, please visit here.

Webinars and Virtual Workshops Webinar Series - Respirators for Health Care Personnel Use during COVID-19 Pandemic The FDA, along with the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA), will host the second webinar in the webinar series on the topic of Importing Respirators for Health Care Personnel Use during COVID-19 Pandemic. Date: June 23, 2020     Time: 12:00 PM - 1:00 PM ET Registration is not required. Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests The FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. Date: June 24, 2020      Time: 12:15 PM - 1:15 PM ET Registration is not required. Webcast - Regulatory Education for Industry: Regulated Bioanalysis Workshop: Requirements and Expectations This training is focused on presenting an overview of how FDA’s Center for Drug Evaluation and Research approaches different issues in bioanalysis. The audience will gain a deeper and broader understanding of how bioanalysis must be performed to adequately support regulated activities and how FDA performs bioanalysis to further the agency’s mission and support regulated industry. Date: June 30, 2020     Time: 9:00 AM - 5:30 PM ET To register for this Webcast, please visit the registration page. Register Here

Consumer Update Helpful Questions and Answers about Coronavirus (COVID-19) and Your Pets

You have probably seen and heard a lot about the coronavirus (COVID-19) and how to keep you and your family safe. But what about the other, furrier members of the family—your pets? Below, the FDA offers some questions and answers to help keep you, your family, and your pets safe during the pandemic.

Q. Can I get COVID-19 from my pet or other animals? A. Based on the limited information available to date, the risk of pets spreading the virus that causes COVID-19 in people is considered to be low. At this time, there is no evidence that animals play a significant role in spreading the virus that causes COVID-19. There is a small number of animals around the world reported to be infected with the virus that causes COVID-19, mostly after having close contact with a person with COVID-19. Continue Reading