FDA News Release
FDA Roundup: June 7, 2022
- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the FDA announced it is considering a master file pilot program for premarket approval (PMA) holders whose approved devices are sterilized using radiation, including gamma radiation. The FDA is considering this pilot program due to global supply chain constraints and to support sterilization supply chain resiliency. If implemented, this program would help medical device manufacturers advance alternative ways to sterilize their approved medical devices, including changing radiation sources, in a least burdensome regulatory approach. The FDA is working actively with sterilization experts, medical device manufacturers, and other government agencies to advance alternative ways to sterilize medical devices, including using lower levels of currently used sterilizing agents and using new sterilizing agents or alternatives, while maintaining device safety and effectiveness. Learn more about the radiation sterilization change master file pilot program under consideration.
- On Monday, the FDA released a new online resource page for human and animal food producers affected by flooding and severe weather incidents such as hurricanes or tropical storms. To help those adversely impacted, this page is meant to replace the individual announcements the agency issued ahead of severe weather such as the one for Hurricane Ida. This new resource will help food producers identify some of the federal and state resources available to those who may be harvesting, mixing, storing, or distributing grains and other foods after experiencing a severe weather incident.
- On Monday, the FDA announced a live webinar titled, “Reporting of Veterinary Drug Supply Chain Information Using the Animal Drug Manufacturing System (ADMS) eSubmitter Tool.” The webinar is intended for animal drug manufacturers, U.S. agents and consultants, and government agencies involved in the pharmaceutical supply chain. The webinar will take place from 1:00-3:30pm ET on Wednesday, June 22, via Zoom.
- On Friday, the FDA cleared the AFib History Feature for use with compatible Apple Watches and Health app. The AFib History Feature is a cardiovascular monitoring device that records the frequency of irregular pulse rhythms to estimate Atrial Fibrillation (Afib) burden. Afib burden is the percent of times a person’s heart is in Afib during a specified monitoring period.
- On Friday, the FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19. Prescribers should review each patient’s full list of medications and use other resources to evaluate for potential drug interactions in patients who take medications that are not included on the Fact Sheet or checklist at this time (a listing of additional resources is provided at the end of the checklist). Please see the updated Prescriber Patient Eligibility Screening Checklist for more information.”
- COVID-19 testing updates:
- As of today, 438 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 308 molecular tests and sample collection devices, 85 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 80 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
- The FDA has authorized 27 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 996 revisions to EUA authorizations
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- FDA Office of Media Affairs