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Drug Firms Have More Time For First Annual Report On Production Volumes US Is Requiring

 
• By Malcolm Spicer

FDA announces day before due date that as it continues considering comments to a draft guidance on the requirement it published in October, the “document is not a binding document” and “the recommended … reporting date for 2020 data is not a requirement.”

• Source: Alamy

The first date manufacturers of OTC monograph drugs and homeopathics marketed without pre-market approval in the US were asked to report annual production volumes isn’t one the Food and Drug Administration is going to enforce.

Firms making those products plus some OTC and Rx approved through applications were expected on 15 February to file their...

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