Typically, when the FDA issues a labeling safety warning, it means that a new warning is being added to existing labeling. However, in an FDA safety notice published today titled FDA Requests Removal of Suicidal Behavior and Ideation [SI/B] Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications (here), the FDA is advising GLP-1 RA […]
I’ve been blogging about FDA Commissioner Markay’s National Priority Voucher program since it was announced in June 2025 (here, here, here, here, and here). In these blogs, I’ve raised the following concerns: The compressed one- to two-month timeframe creates a potential opportunity for missing something important during these reviews. With the competition for resources for […]
I usually get a flu shot around this time each year and, in recent years, an updated COVID vaccine. I sit at my computer, go on my local retail pharmacy’s website, and select a date for my immunizations in the not-too-distant future so I’ll have adequate protection during that flu season. In addition, I’m convinced […]
In December, the third month of FY 2026, the number of unofficial approval actions fell significantly from those in the first two months, with the OGD issuing 41 full-approval actions and 13 tentative-approval actions for a total of 54. * December numbers are unofficial but should be close to final. The reasons are not obvious as […]
The official November 2025 OGD statistics are in the books and, as far as approvals are concerned, the OGD had a good month with 58 full approvals and 26 tentative approvals reported. Of the 58 full approvals, 6 were for first-time generics; however, only 6 (10%) were first-cycle approvals. This is one of the lowest […]
In a prepublication Federal Register notice here, the FDA announced its FY 2026 OTC monograph order requests (OMOR). The Agency has indicated that it will publish the FY 2026 OMUFA facility fee rates (i.e., monograph drug facility (MDF) and contract manufacturing organization (CMO) facility fee rates) in a subsequent Federal Register notice. There are two tiers of […]
Once again, here we are, at the end of the year, Unprecedented changes we may even fear. So much disruption at the FDA, Five CDER Directors in one year, seems like one per day. Institutional knowledge leaving through the revolving door Makes my brain spin and feel very sore. Will the new folks in charge […]
The FDA has issued a final Guidance for Industry titled Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act (here). It provides guidance for sponsors and others on dispute resolution and hearing processes with the Center for Drug Evaluation and Research (CDER) once the […]
The FDA reports 27 full-approval actions and 9 tentative-approval actions through December 17, 2025 as posted on its daily (here) and all approvals (here) pages. This total of 36 full- and tentative-approval actions appears to be on the average side and, with the holiday coming up and the number of employees likely absent for vacation, it […]
In an email announcing the two new guidances, the FDA said, “[t]he first guidance titled Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices is intended for investigators, industry, and institutional review boards (IRBs). This final guidance provides recommendations to help clinical investigators comply with the safety reporting requirements for investigational new drug application […]
