As the FDA’s first ANDA suitability petition coordinator at the time of the initial passage of Hatch-Waxman as well as having been involved for my full ten years at the FDA and 30+ years in industry, I’ve seen a lot of suitability petitions, a lot of responses, and some strange things in my day. I’ve also […]
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 […]
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 […]
We’ve been waiting for the first Generic Drugs Program Monthly and Quarterly Activities Report to be published for FY 2026, and it arrived sooner than expected! There’s at least one surprise and there are a few other interesting observations that we will discuss regarding new ANDA submissions for October 2025. But first, let’s talk about approvals. […]
Don’t blink – things can change in a minute, or at least in one day. After our blog post yesterday on mid-month approval actions for the OGD, a flurry of activity occurred in the postings from a few days past. The new mid-month approval actions can now be reported as 38 full-approval actions (that’s 12 […]
There are two federal holidays, Veterans Day and Thanksgiving, in November, making it a crazy month. Lots of Agency staff take vacation around the two holidays, and Thanksgiving week is particularly laden with staff vacation days, which is little surprise as it is one of the busiest travel times for everyone in the U.S. Despite […]
The Office of Generic Drug has published the newly revised Manual of Policy and Procedures (MaPP) 5016.8 titled Using Four-Part Harmony in Quality-Related Assessment Communications (here). The-Four Part Harmony assessment is used in several of the Agency’s Centers and its goal is to promote communication clarity between reviewers and applicants. It also answers the questions of […]
The OGD got back to business right away after the government reopened by publishing the final guidance titled Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Guidance for Industry (here). The issue of changing pH-adjuster ingredients for the purposes of creating a generic formulation of […]
In an announcement today, the FDA has explained its decision to revise the labeling of hormone replacement therapy (HRT) products based on reevaluation of older studies in light of new data. The FDA recognizes a difference between the risks associated with oral HRT products vs. vaginally applied HRT products and the labeling changes reflect this […]
