FDA Adds 34 New and 33 Revised Bioequivalence Study Recommendations for Generic Drug Developers

Tuesday, October 4, 2016

Source: RAPS

The US Food and Drug Administration (FDA) on Tuesday published 67 generic drug-specific recommendations (34 new and 33 revised) describing the agency’s expectations for developing generics that are therapeutically equivalent to reference-listed drugs (RLDs).

The guidance is intended to help the generic pharmaceutical industry identify the most appropriate ways to generate evidence needed to support abbreviated new drug application (ANDA) approval.

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