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Helping Manufacturers Navigate Novel Coronavirus Variants

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME

The FDA is developing guidance for manufacturers of diagnostics, therapeutics, and vaccines to aid their response to emerging severe acute respiratory syndrome coronavirus 2 variants, Acting Commissioner Janet Woodcock, MD, said in a statement.

Woodcock said FDA officials don’t believe they’ll have to “start at square one with any of these products—we recognize we are in a pandemic and we need to arm health care providers with the most appropriate tools to fight this pandemic on the frontlines. We do not want to create obstacles to getting these tools to the frontlines.”

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The FDA is developing guidance for manufacturers of diagnostics, therapeutics, and vaccines to aid their response to emerging severe acute respiratory syndrome coronavirus 2 variants, Acting Commissioner Janet Woodcock, MD, said in a statement.

Woodcock said FDA officials don’t believe they’ll have to “start at square one with any of these products—we recognize we are in a pandemic and we need to arm health care providers with the most appropriate tools to fight this pandemic on the frontlines. We do not want to create obstacles to getting these tools to the frontlines.”

The approaches include accelerating the evaluation of new monoclonal antibodies that may be effective against variants. The FDA acknowledged that some authorized monoclonal antibodies and others still under development are less effective against certain variants.

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