FDA COVID-19 Update

Tuesday, July 14, 2020

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • Given the anticipated increase in demand for chloroquine phosphate and hydroxychloroquine sulfate, the FDA is taking steps to ensure that adequate supply of these drug products is available for patients:
    • Today, the FDA published product-specific guidances (PSGs) to support generic drug development for these drugs. The new PSG for chloroquine phosphate clarifies that the product is AA rated in the Approved Drug Products with Therapeutic Equivalence Evaluations publication (Orange Book), meaning that there are no known or suspected bioequivalence problems, and no in vivo studies are necessary. The revised PSG for hydroxychloroquine sulfate adds advice about a Biopharmaceutics Classification System-based biowaiver option.
    • The FDA is currently prioritizing review of any newly submitted Abbreviated New Drug Applications (ANDAs) for chloroquine phosphate and hydroxychloroquine sulfate under MAPP 5240.3: Prioritization of the Review of Original ANDAs, Amendments, and Supplements.
  • The FDA added new questions and answers to the webpage Q&A for Consumers: Hand Sanitizers and COVID-19. These new questions focus on unintentional ingestion of hand sanitizer by children, as there has been an increase in calls to Poison Control for unintentional ingestion of hand sanitizer during the COVID-19 pandemic.
  • The FDA issued an Emergency Use Authorization (EUA) for the emergency use of the Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, and Outlook ES (“B. Braun Space and Outlook Pumps”) for use in the tracheal delivery of continuous nebulized medications into a nebulizer to treat patients of all ages with or suspected of having COVID-19 and decrease the exposure of healthcare providers to such patients during the COVID-19 pandemic. The EUA was also issued for ground medical transport use of the Infusomat Space Volumetric Infusion Pump System.
  • Diagnostics update to date:
    • During the COVID-19 pandemic, the FDA has worked with more than 300 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
    • To date, 34 emergency use authorizations have been issued for diagnostic tests.
    • The FDA has been notified that more than 180 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
    • The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

Additional Resources:

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc.

WE WELCOME YOUR VIEWS

Please enter your comment!
Please enter your name here