Today, the FDA issued twenty-six new and six revised Product Specific Guidances (PSGs) (here). PSGs provide the Agency’s current thinking on acceptable methods for demonstrating bioequivalence between the Reference Listed Drug or the Reference Standard designated by the Agency (if the RLD is no longer available) and the proposed generic product. These latest PSG additions […]
At the Center for Drug Evaluation & Research (CDER) Small Business Industry Assistance (SBIA) meeting held on April 25th, titled “Facilitating Generic Product Availability Through Product-Specific Guidances (PSGs) for 2024,” the FDA presented some updates regarding the FDA Dissolution Database. Dr. Leah Falade, Senior Pharmacologist in the Office of Pharmaceutical Quality, CDER, was the presenter in Session 6. […]
The FDA recently hosted a webinar focused on the facilitation of generic drug product development through Product Specific Guidances, also known as PSGs. The CDER Small Business & Industry Assistance (SBIA) held a webinar titled Facilitating Generic Product Availability Through Product-Specific Guidances (PSGS) for 2024 on April 25th. The slides and recordings will soon be posted […]
What is the answer to the question? Apparently, at the FDA’s Center for Drug Evaluation and Research (CDER) Small Business Industry Assistance (SBIA) Generic Drug Forum for 2024 (held April 10-11), it was Controlled Correspondence (CC). The FDA conducted two presentations exclusively on CCs and responded with that answer on more questions than not throughout […]
First, please be aware that many of the numbers you may have seen reported in our blog posts for various OGD actions were reported for Fiscal Year 2023, which ran from October 1, 2022 through September 30, 2023. The Office of Generic Drugs 2023 Annual Report (here) is a bit different as it reports OGD actions from […]
Today, the OGD published a list of 29 new Product-Specific Guidances (PSGs) and 33 revisions to existing PSGs, all of which have been added since February 15, 2024. The listing can be found here. This publication is different than the one we wrote about in another blog today regarding the FDA’s plans for issuance of new […]
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 […]
