Big Day for FDA and OGD Bioequivalence Information

Today, the FDA announced the issuance of a revised draft guidance titled Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA Guidance for Industry (here).  This 42‑page guidance supersedes the December 2013 draft guidance of the same name.  The document provides updated recommendations and the FDA’s current thinking on the general concepts for […]

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New Complex Generics PSGs Planned as Well as Some Revisions

Today, the FDA debuted a new page on their website called Upcoming Product-Specific Guidances for Complex Generic Drug Product Development.  Its stated purpose is to provide “information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective complex generic drug products.”  This comes after several public […]

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