Contract Pharma Staff05.01.20
The U.S. FDA has taken the following action as of April 30th in the ongoing response effort to the COVID-19 pandemic:
- Tthe FDA included, under the ventilator emergency use authorization (EUA), a ventilator developed by the National Aeronautics and Space Administration (NASA), which is tailored to treat patients with COVID-19. The ventilator was added to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator EUA that was issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic.
- The FDA issued a Consumer Update, Helpful Questions and Answers about Coronavirus (COVID-19) and Your Pets, that provides answers to frequently asked questions. 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.
- The FDA issued a guidance highlighting flexibility under the Drug Supply Chain Security Act (DSCSA). This guidance is intended to facilitate the distribution of prescription drug products needed to respond to COVID-19, including drugs to treat symptoms of COVID-19. During the COVID-19 emergency, the DSCSA requirements related to certain product tracing and product identification activities, and wholesale distribution, do not apply to qualifying distribution activities. This flexibility balances the need for effective distribution of products under emergency conditions with protecting consumers from exposure to products that may be counterfeit, stolen or otherwise harmful.
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Diagnostics Update to Date
- During the COVID-19 pandemic, the FDA has worked with more than 380 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
- To date, the FDA has issued 53 individual emergency use authorizations for test kit manufacturers and laboratories. In addition, 23 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
- The FDA has been notified that more than 235 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.
