17
Nov

FDA Provides Thanksgiving Gift of 49 New and Revised Product Specific Guidances (PSGs)

In its never-ending quest to provide timely guidance on bioequivalence requirements for generic versions of brand name products, today, the FDA published 29 new and 20 revised BE guidance recommendations in the pre-publication of Federal Register Notice (here) as well as on their website (here, hint: look for the newly added and revised links on […]

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20
May

More PSGs Issued by OGD

Yesterday, the Office of Generic Drugs released twenty-four new and thirteen revised Product Specific Guidances (PSGs) with recommendations for conducting studies necessary to establish bioequivalence between test and reference products.  Of course, the revisions might spell trouble for applicants that have already commenced testing according to the original guidances, but this has been a bone […]

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20
Aug

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Today, the FDA announced the issuance of a revised draft guidance titled Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA Guidance for Industry (here).  This 42‑page guidance supersedes the December 2013 draft guidance of the same name.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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19
May

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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