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US FDA Will Allow Transitioning Products To Continue Referencing Drug Master Files

 
• By Derrick Gingery

The 'technical detail' needed to be resolved in part to ensure there would be no shortages after the 2020 change from regulation as drugs to biologics for certain protein products, the agency said.

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The FDA's proposed rule is intended to ease the burden of the 2020 biologics transition process. • Source: Shutterstock

A subset of products subject to the biologics transition process in March 2020 may continue using drug master file information after they become biologics license applications, even though the US Food and Drug Administration currently prevents the practice.

The FDA issued a proposed rule 27 June that would allow these products, which include some reproductive hormones and enzymes, to continue referencing drug substance, drug intermediate and drug product information from master files once they

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