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 […]
At the MedTech Forum 2022 in Barcelona, there was a tense and “standing room only” moderated session on the looming May 26, 2024 EU Medical Device Regulations (MDR) implementation deadline. Representatives from the notified bodies, competent authorities, industry, and other trade groups had a very intense interchange about the deadline, which requires all companies selling […]
Surprise, surprise! Just yesterday, we reported an anemic number of approvals through May 16th and today we were surprised to see (perhaps due to a fix to the FDA’s posting problem!) the new and now revised total through May 17th is thirty‑seven full‑approval actions (only one of which was approved on the 17th) and still one tentative […]
According to the reporting on the FDA’s Daily Approvals page and confirmed by the FDA’s All Approvals list at 9:45 AM, EST 5/18/22, there were a total of 15 full approval actions and one (1) tentative approval action so far in May. Could the glitch previously reported here still be a problem? We all hope […]
When reviewing health agency citations, investigators are naturally concerned when observing cases of data invalidation during investigations and may well question the motives/justification accordingly. This can lead to some uncomfortable exchanges between firms and health agencies! So how should a laboratory protect themselves from such a situation? First, you want to ensure that, per your […]
We can all sleep at night now, as OGD presented the official approval action numbers today (here) and the computer glitch that was reported earlier is in the rearview mirror (for now at least). The good news is that OGD reported a total of 62 approval actions (20 more than appear on the FDA’s All […]
In my post of May 3rd (here), I raised a concern about the number of approvals posted in the month of April 2022 and the fact that there were quite a few days in April where there were no or few approvals posted. I followed up with the FDA Press Office to see what was […]
Tuesday’s session of the Fiscal Year (FY) 2022 Generic Drug Science and Research Initiatives Public Workshop opened with a presentation by Michael Banks, Senior Vice President, Global Head Regulatory Affairs, Teva Pharmaceuticals discussing the global challenges to the development of complex generic drugs. Dr. Banks challenged the regulatory bodies to move towards more standardized approaches […]
The FY 2022 Generic Drug Science and Research Initiatives Public Workshop held May 9-10, 2022, addressed a significant number of complex drug product questions as well as feedback from the industry as to what steps would be helpful for FDA to undertake to facilitate complex product development, review, and approval. With GDUFA III considered to […]
In a previous blog post (here), we discussed the results of an April 16, 2021 decision by the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA, 2021 (U.S. App. Lexis 10928 [April 16, 2021]) which the FDA decided not to appeal. This court decision dealt with […]
