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 […]
The Official Generic Drug Monthly Statistical report has issued (here) and is in a new format. As of this morning (August 5), the charts for the June data have not been updated; however, if you scroll down to the “Download Monthly and Quarterly Activities Dataset” button you can find the data metrics for June. Let’s […]
Usually, every quarter, the FDA issues a series of new and revised product specific bioequivalence guidances designed to provide the industry with FDA’s current thinking on the appropriate methods to establish bioequivalence of certain products. Today, FDA issued a list (here) composed of only newly revised guidances and all of them are for injectable peptide […]
With four and a half months remaining in fiscal year 2026, the Center for Drug Evaluation and Research (CDER) has published the list of 85 new or revised guidance documents that it plans to release this year! The document (here) categories along with the number of anticipated guidances are as follows: Administrative/Procedural – 8 Artificial […]
The OGD released its May 2026 Generic Drugs Program Monthly and Quarterly Activities Report (here) late Tuesday evening. In our blog covering unofficial May mid-month approval actions (here), we surmised that the final ANDA approval numbers would be significantly lower than the May numbers when the official metrics came out and we were right… they […]
Here we are, in the middle of June already! Where does the time go? If you have a few minutes away from scanning the World Cup results, let’s see how the OGD is doing, as far as approvals go, during the first fifteen days of the month. As of June 15th, the OGD has issued […]
In the Federal Register of March 3, 2026, the FDA published a request for information and comments on the Agency’s series of guidances for industry on Scale-Up and Post-Approval Changes (SUPAC) for specific dosage forms. Based on the requests received from interested parties, the FDA is reopening the comment period and extending it for an additional […]
In this morning’s Federal Register pre-notification page (here), the FDA announced the addition of 23 new Product-Specific Guidances (PSGs) and 48 revised PSG documents. The FDA began publishing PSGs on June 11, 2010 when it announced its first group of PSGs to assist firms in understanding the FDA’s current thinking on the bioequivalence requirements for specific […]
While April showers may bring May flowers, the number of unofficial April ANDA approvals sure is a welcome event. April saw full approval of 87 ANDAs, the highest number since August 2023 when the FDA approved 98. April’s total was bolstered by the 24 full approvals of dapagliflozin single entity and combination products on April 6th. […]
The Generic Drugs Forum for 2026 got off to a great start this morning. The two-day session is covering the “soup to nuts” of interest to generic drug sponsors. Here are just a few tidbits from this morning’s session: The Refuse-to-Receive (RTR) rate for original ANDA submissions dropped from a high of 10.9% in […]
