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The Vaccines and the Variants

FDA provides requirements that will allow for a much quicker authorization of “booster shots” for existing vaccines for use against variants or mutations of the coronavirus. The FDA has just released an updated Guidance...more

FDA Issues Guidance On What To Do if Employees Test Positive for COVID-19

The FDA has just issued a Guidance on what it considers to be appropriate Current Good Manufacturing Practices (CGMPs) for Responding to COVID-19 infections in employees in drug and biological manufacturing facilities. ...more

FDA Removes Certain Serology/Antibody Tests From the Market

The FDA has just published a list of certain already-on-the-market serology/antibody tests from commercial manufacturers that should not be distributed unless and until an Emergency Use Authorization (EUA) is issued for the...more

FDA Loosens Requirements for Sterilizers, Disinfectant Devices, and Air Purifiers

Over the past weekend, the FDA issued yet another Final Guidance to relax the rules governing medical devices. In this new Guidance, the FDA says it is expanding “the availability and capability of sterilizers, disinfectant...more

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