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 […]
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 […]
Yesterday, the Agency expressed confidence that manufacturers of varenicline tablets containing the N‑nitroso-varenicline impurity can meet the FDA’s original acceptable intake limit of 37 ng or less per day. Their statement read: “FDA is now confident in manufacturers’ ability to supply patients with varenicline containing the N-nitroso-varenicline impurity at or below the agency’s acceptable intake limit […]
The March statistical update to the Generic Drugs Program Activities Report – Monthly Performance brings the refuse-to-receive (RTR) count back to a manageable number of three, which has been seen every month so far this FY except for last month, which saw triple that number. The OGD also acknowledged sixty‑two ANDAs in March. Other metrics […]
At the Generic Drug Forum virtual SBIA event that is still ongoing, Andrew J. Fine, PharmD, BCPS, Senior Advisor, Division of Clinical Review, Office of Safety & Clinical Evaluation, Office of Generic Drugs, provided a look at the type of information that needs to accompany a complex product (particularly a drug device combination) to establish […]
