This is the second edition of the “Did You Know?” series featuring some of the lesser known (or at least widely known) aspects of the GDUFA III program changes and the impact on the generic drug industry. Today we will focus on elements of Pre-ANDA Development Program. GDUFA III has opened the door for additional […]
The CDER Small Business and Industry Assistance (SBIA) presented a two-day seminar on April 12-13, 2023, celebrating the first 10 years of GDUFA. With the Office of Generic Drugs and industry now operating under the third iteration of GDUFA, the presentations by FDA Agency covered a lot of ground in an effort to highlight the […]
With half of April in the books, the number of OGD approval actions posted as of April 14th includes twenty‑seven full‑approval actions and four tentative‑approval actions for a total of thirty‑one approval actions. It looks like the OGD is heading towards an average approval month for April. Average definitely isn’t a bad thing, especially since […]
Those of us that have been in the trenches since the passage of Hatch-Waxman have seen the issue of adhesion and sensitization studies for transdermal delivery systems (TDS) change dramatically. Well, there are now two new guidance documents that take us to the next step in recommended adhesion and irritation/sensitizations (I/S) testing revisions. First is […]
Those of us in the industry are usually reasonably technically savvy and can understand some of the more complex guidance documents that the FDA issues. However, there are times that even those among us in the industry, depending on our individual academic tracks and professional experiences, whether regulatory, CMC, bioanalytical, pharmacokinetics, medical, and on and […]
March 2023 was an outstanding month for approval actions, with OGD unofficially issuing 123 total approval actions comprised of 95 full approval actions and 18 tentative approval actions. There were other months with 100 or more total approval actions, but we have not seen that level of approval productivity in a while. The record of […]
After 12 years on the market under an accelerated approval, the application holder for Makena has failed to provide sufficient efficacy data to the FDA to support continued marketing. The FDA said “[T]oday, the U.S. Food and Drug Administration announced the final decision to withdraw approval of Makena.” The 26 page final decision (here) can […]
I’ve been blogging about the chilling and hugely negative impact that the court decisions in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., No. 18‑1976, have on the delicate balance between the generic and brand‑name industries struck by the Drug Price Competition and Patent Term Restoration Act of 1984 (better known as the Hatch-Waxman Act). I won’t recount the […]
Emergent Bio Solutions received FDA approval today to market an over the counter (OTC) 4mg nasal spray to reverse opioid overdose. What does that mean to the public and the industry? For the public, as soon as the company begins distributing the product, it means easy access to a potentially lifesaving emergency medication to treat […]
When we looked at the mid-month February approvals back on February 22 (here), we projected that February might be a slim month for full approvals and we were right. OGD issued a total of 46 approval actions in February, the lowest total for a month thus far this fiscal year (FY). Of the 46 full […]
