In an alert yesterday from the FDA (here), the Agency indicated that it was changing the TE code of Accord Healthcare’s product (ANDA 091195) from AB (substitutable) to BX (“not sufficient information to demonstrate that Accord Healthcare Inc.’s tacrolimus oral capsules provide the same therapeutic effect as Prograf (tacrolimus) oral capsules”). Tacrolimus is used for […]
Today, the FDA released another batch of Product‑Specific Guidances (PSGs), outlining its current thinking on the bioequivalence (BE) testing requirements for generic products – twenty‑five new BE guidances and twenty‑one revised guidances. The listing can be found here. The FDA has various goals regarding publication of these PSGs that are tied to getting information to […]
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 […]
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 […]
Today, the FDA announced the issuance of a revised draft guidance titled Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA Guidance for Industry (here). This 42‑page guidance supersedes the December 2013 draft guidance of the same name.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 […]
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 […]
