Not the best news (even unofficially), as OGD unofficially issued only 41 full approval actions in August. This represents the lowest monthly number of full approvals in all of FY 2026 to date and with just one month left in this FY, OGD may be scrambling to get more out the door. Although if the […]
We are coming up to the end of another Fiscal Year and the OGD has just 2 months of official stats to report. Here is what Happened in July. OGD approved 68 new ANDAs and issued 18 tentative approval actions in July. Of the 68 newly approved ANDAs, 6 were for first-time generics and 11 […]
In November 2025 the FDA requested that manufacturers of hormonal treatments for menopausal symptoms make changes to the labeling to remove boxed warnings about a probable risk of breast cancer, cardiovascular disease, and probable dementia because new information evaluated by the Agency has made those warnings obsolete. These changes in labeling have had a dramatic […]
The Federal Register pre-publication notice published today (here) lists Etomidate as a product with possible abuse potential that will be reviewed for scheduling under the Controlled Substances Act. It is a short-acting anesthetic and mentioned often on TV medical shows when a patient is brought into the ER either unresponsive or in need of immediate […]
Today, the FDA published 55 product specific guidances (PSGs) that provide FDA’s current bioequivalence recommendations for generic products. The PSGs can be found here and the current listing represents 24 new and 31 revised PSGs. FDA says that today’s batch of 55 PSGs contain: More than 30 for products with no approved ANDAs including 15 […]
Today, the FDA issued the final guidance titled Evaluation of Therapeutic Equivalence (here). The guidance is essentially identical to one with the same title issued in July 2022. There are only a few changes from the draft guidance, which include revisions to reflect an additional process by which applicants of certain 505(b)(2) applications may request […]
August has brought a lot of heat over most of the US. So far this month, the descriptor of “hot” does not appear to apply to the pace of ANDA approval actions. Maybe the review folks from FDA are escaping the heat on vacation but through August 15th, OGD has posted only twenty ANDA approval […]
Today, the FDA has published revision 1 (here) of the draft guidance Determining Whether to Submit an NDA or a 505(b)(2) Application issued in May 2019. Its purpose is to further define which abbreviated pathway, ANDA, or a 505(b)(2) application, is the appropriate submission type for the market application. The guidance first defines what a […]
The Agency has issued a 37-page draft guidance (here), that describes FDA’s current thinking regarding a wide range of issues regarding various container closure systems, packaging components and testing requirements to ensure that the proposed container closure system is appropriate for the proposed drug product. FDA says that when finalized, this draft guidance will “supersede […]
After months of negotiations, the FDA published a proposed Commitment Letter for GDUFA IV, which will outline the OGD and Industry’s agreements regarding all aspects of the ANDA review and approval process. The proposed commitment letter can be found here. The 48-page document addresses all issues that have undergone negotiations regarding the proposed new iteration […]
