FDA Provides New & Revised Product-Specific Guidances

The U.S. Food and Drug Administration (FDA) has issued 22 new and 14 revised product-specific guidances (PSGs) for generic drug development. The guidances provide further clarity to the FDA’s expectations in regards to clinical studies demonstrating bioequivalence (BE) to a reference listed drug (RLD). “With the revisions to these two PSGs, FDA aims to facilitate greater access to affordable generics by providing the generic industry with the Agency’s current scientific thinking for establishing BE for generics referencing Alvesco and Atrovent HFA, neither of which has an approved generic,” FDA says. The latest release of the 36 guidances brings the total number to 1,885 PSGs.

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