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FDA Email Alert: Next Day’s Manufacturing Volume Reporting Due Date Still Voluntary

 
• By Bowman Cox and Shannon Brown

Objections to 15 February reporting date established in draft guidance spurred rare last-minute notice assuring industry that it was a non-binding recommendation, not a requirement. Action reflects confusion that can arise in interpreting policy guidance.

When time is melting
when regulatory deadlines melt away • Source: Alamy

The US Food and Drug Administration took the unusual step 14 February of alerting industry by email that a 15 February date for initial pharmaceutical manufacturing volume reports, while recommended, was not required.

Section 3112( e ) of the Coronavirus Aid, Relief and Economic Security (CARES) Act added the reporting requirement to the Food, Drug & Cosmetic Act in a new Section 510(j)(3)....

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