FDA Stakeholder Update - May 8, 2020

Dear Colleague,

As our health care providers and essential personnel work on the front lines of the COVID-19 pandemic, we want you to know we are here to help you 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 products continues to be a top priority for the FDA.

Updates

May 8, 2020 - FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens May 7, 2020 - Visit our “At-A-Glance” resource summarizing the FDA COVID-19 Response May 7, 2020 - Daily Roundup May 7, 2020 - Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization: Letter to Health Care Providers May 7, 2020 - FDA Continues to Combat Fraudulent COVID-19 Medical Products May 6, 2020 - Daily Roundup May 6, 2020 - FDA Approves First Targeted Therapy to Treat Aggressive Form of Lung Cancer May 5, 2020 - FDA Approves New Treatment for a Type of Heart Failure

Guidance Documents

May 7, 2020 - CVM GFI #271 Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency May 6, 2020 - Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff May 5, 2020 - Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components: Guidance for Industry May 4, 2020 - Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff

For a more comprehensive list of all official FDA Guidance Documents and other regulatory guidances, please visit here.

FDA Voices Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy By: Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs, and Jeff Shuren, M.D., Director, Center for Devices and Radiological Health

As we at the FDA have said before, every step we have taken in our approach to COVID-19 testing has been a careful balancing of risks and benefits – all done to anticipate and meet continuing and evolving public health needs as we combat this virus. That’s why the FDA issued an update to a policy from March 16, 2020 on antibody tests for COVID-19.

High-quality antibody tests (a type of serological test) can help us understand a person’s and population’s exposure to COVID-19. A person who has been exposed to, and recovered from, COVID-19 will likely have antibodies to the SARS-CoV-2 virus in their blood. These tests may be important for guiding our next steps in the fight against this pandemic, such as by providing information on disease prevalence and the frequency of asymptomatic infection, and also by identifying potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe or immediately life-threatening disease.

Webinars and Virtual Workshops

Conversations on Cancer:  OCE Salutes the Mosaic of Oncology Nursing

Date: May 19, 2020  Time: 2:00 PM - 3:00 PM EDT To register for this WebEx, please visit the registration page

Register Here

Botanical Safety Consortium Annual (Webcast) Meeting The Botanical Safety Consortium (BSC), a forum established by the FDA, the National Institute of Environmental Health Sciences (NIEHS), and the Health and Environmental Sciences Institute (HESI), will hold its first annual meeting. The meeting includes recruiting new members and soliciting input into current scientific challenges and opportunities related to botanical ingredient safety. Date: May 29, 2020 Time: 9:00 AM - 12:45 PM EDT To register for this webcast, please visit the registration page

Register Here

Consumer Updates

Your Animal Is Sick. Was It Something They Ate? Vet-LIRN May Be Able to Help

Your family’s beloved “Fluffy” has gotten sick after eating a certain food, and neither you nor your veterinarian is sure if that food, or something else, is the cause. What happened? And is your animal the only one that’s sick, or are there others? Vet-LIRN (Veterinary Laboratory Investigation and Response Network), a program from the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM), is a special network that connects laboratories around the country looking for clues that might solve animal illness mysteries. Vet-LIRN allows FDA to partner with state and university Diagnostic Laboratories.