US FDA, USP Cooperate On Small Molecule Drug Monograph Updates To Speed ANDAs

Generic applicants can request monograph changes while FDA assessment is ongoing.

Generics
Using the USP Pending Monograph Process could help generics reach the market faster, US FDA says. • Source: Shutterstock

Generic drug sponsors deviating from US Pharmacopeia standards can now petition for a monograph change before receiving application approval, a practice the US Food and Drug Administration endorses as part of its effort to lower drug costs.

New FDA draft guidance released 10 July encourages ANDA sponsors that will need to request changes to the official...

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