COVID-19 Update: FDA Response

Jun 4, 2020 | COVID-19

The Food and Drug Administration (FDA) announced the following actions in response to the COVID-19 pandemic.

Testing Supply Substitution Strategies

The FDA announced a new web-based resource that contains detailed information to help support labs performing authorized COVID-19 tests. This interactive tool includes validated supply alternatives that labs can use to continue performing testing when there is a supply issue with some components of a test. The information in this resource is not intended to alter any already issued Emergency Use Authorization for a COVID-19 diagnostic test, nor is it intended to speak to any specific FDA regulatory requirement. Rather, the information is being provided to help address availability concerns regarding certain critical components of COVID-19 diagnostic tests during this pandemic. More Information.

COVID-19 Expanded Access Guidance

The FDA published guidance titled Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency: Guidance for IRBs and Clinical Investigators, which includes recommendations regarding procedures for single IRB member review. This is in response to physician requests for a waiver from the requirement for full IRB review. The guidance recommendations also address factors to consider when assessing potential benefits and risks for a particular patient being treated under expanded access. More Information.

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