As of postings today on the Recent New and Generic Approvals site (here), the Office of Generic Drugs (OGD) has issued 58 full approval actions and 12 tentative approval actions for a total of 70 actions in November 2024. In our unofficial count for October 2024 reported in our blog post here, we reported that […]
For certain “companies that first registered with the FDA during the COVID-19 public health emergency (PHE) solely for purposes of manufacturing OTC hand sanitizer products during the PHE were not identified as facilities subject to the OMUFA facility fee, for a certain time period. That time period, which extended beyond the end of the PHE, […]
We all know what an expiration date is, or what it is supposed to be, for a drug product. It is a date after which the product could begin to lose its label-stated claim of the drug potency. For some products (like prescription tetracycline), degradation products could form post expiration date that could make taking […]
For those of you who follow the daily approvals page (here), on November 21, 2024, there was a flurry of supplemental labeling approvals listed for drug products that contain non-steroidal anti-inflammatory drugs (NSAIDs), from aspirin to Zipsor (diclofenac potassium). In today’s CDER Drug Safety-related Labeling Changes (SrLC), the new, revised warning that must be included was […]
Having been around the block more than a few times, the position of the FDA regarding pricing is clear. The Agency is not supposed to take pricing considerations into drug approval or enforcement decisions. However, there is controversy swirling around the FDA’s recent decision on the drug shortage for GPL-1 obesity medications and the practice […]
President-elect Donald Trump has selected Dr. Martin Makary to lead the Food and Drug Administration. Makary is a surgeon from Johns Hopkins who has been fairly outspoken regarding the Agency that oversees our drug and food supply. He appears to be critical of some of the Agency’s decision-making processes and it looks like he will insert […]
Wow, what a year! November has been the most stressful month I can remember in a long, long time. But is it over or just beginning? It depends on your point of view. I know the folks at the FDA are a bit nervous, as well as those at the NIH, CDC, and other federal […]
Yesterday, we published a blog (here) regarding the newly issued and revised PSGs. I pointed out one example of something that I hadn’t seen before relative to products subject to ANDA suitability petitions. I thought I’d missed something along the way, but I’m glad to say that, no, I did not! In an email today […]
The OGD posted 29 new and 31 revised product-specific guidances (PSGs) today (see here). The new list of PSGs covers drugs with various dosage forms including tablets, capsules, gels, oral suspensions, intramuscular extended-release suspensions, topical solutions, powders, ointments, other parenteral products and orally disintegrating tablets, and subcutaneous extended-release suspensions. One of the new PGSs for […]
Turkey month has two holidays baked into the calendar and that will likely have some impact on approvals reported this month, especially since the Thanksgiving holiday usually is a super short week, as people take multiple days off! Looking at where the unofficial metrics stand, as of today, the OGD has issued 30 full approval […]
