According to the first FY 2025 Generic Drugs Program Monthly and Quarterly Activities Report (here), the OGD had a good month for approval actions, issuing 62 full-approval actions and 20 tentative-approval actions for a total of 82. Only one month in FY 2024 had a higher combined total for these two metrics. That’s the good news! The […]
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 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 […]
The holidays are fast approaching and many of us are in a joyful spirit, more prone to giving and charity in alignment with the season. That said, considering the effort that goes into sponsors’ pursuit of ANDA approvals where the sponsor or sponsors may be eligible for 180-day exclusivity, I doubt that anyone in the […]
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 […]
The new 2025 Fiscal Year (FY) looks like it is off to a great beginning with OGD unofficially issuing 61 full approval actions and 22 tentative approval actions for a total of 83 total approval actions. While the numbers look good, it should be noted that the only month in FY 2024 that had more […]
When addressing the requirements of analytical test procedures, 21 CFR 211.160 states: “Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.” 21 CFR […]
A pre-publication Federal Register notice today (here) announced the first group of product-specific guidances (PSGs) for which the requirement for a fed, in-vivo bioequivalence (BE) study has been removed. In some instances, the fasting, in vivo bioequivalence requirements were modified such that now only one in vivo study will be required to support a bioequivalence […]
