As the FDA’s first ANDA suitability petition coordinator at the time of the initial passage of Hatch-Waxman as well as having been involved for my full ten years at the FDA and 30+ years in industry, I’ve seen a lot of suitability petitions, a lot of responses, and some strange things in my day. I’ve also […]
Today, the FDA issued 44 new and 37 revised draft product specific guidances (PSGs) outlining FDA’s current thinking on the requirements for establishing bioequivalence to reference listed drugs or reference standards. None of the guidance documents were finalized in the current listings. According to the FDA Email, the 81 guidance documents included (and yes, I […]
Even after he originally said that he wasn’t interested in the job, Richard Padzur, M.D., a long-time (26-year!) veteran of the FDA, was named Director of the Center for Drug Evaluation and Research. As the founding director of the FDA’s Oncology Center of Excellence and in his tenure leading the Oncology Division, Dr. Padzur has been […]
Priority review vouchers are awarded to the sponsors of applications for tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) products that gain approval. The new fee for use of a priority review voucher is the same for each type of voucher as identified in the table below: The pre-publication Federal Register Notice […]
Today, May 22, 2025, “[t]he U.S. Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) issued General Correspondence Letters to two third-party testing companies in China after discovering data that was falsified or otherwise found to be invalid” (see the FDA announcement here). The two labs receiving the so-called General Correspondence Letters are […]
Yesterday, the FDA published a “reminder” clarifying the status of compounded Tirzepatide now that the shortage for this GLP-1 product has been resolved. After confirming with the approved manufacturer of Tirzepatide that they now have sufficient supplies to meet current market demand, FDA is “reminding” both 503A and 503B compounders that, since the product is […]
On September 20, 2024, we posted a blog on the changes that are being contemplated by the FDA with issuance of the final M13A guidance (here). One of the major changes delineated in this guidance was elimination of the previous requirements for fed bioequivalence studies in over 850 different Product Specific Guidances (PSGs) for solid oral […]
In a pre-publication Federal Register notice issued today (here), the FDA announced a draft guidance titled Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers: Guidance for Industry (here) to further promote the Agency’s knowledge and view that biosimilars and interchangeable biosimilars are really the same (although the Agency doesn’t come right […]
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 […]
Well, we hit the nail on the head (at least for approval actions in March)! As predicted in our April 5th post (here), OGD issued 48 full approval actions and 13 tentative approval actions for a (low) total of 61 approval actions, and that is exactly what OGD is reporting in its official monthly stats […]
