It seems that the pace of approvals in July 2024 slowed and, as a result, our mid-month estimate of possibly hitting 90 approvals was dashed by a late-month drop in approval actions. The OGD did, however, unofficially issue 63 full-approval actions and 12 tentative-approval actions for a total of 75. (As a reminder, at mid-month, the OGD had […]
On May 1, 2024, the first version of USP General Chapter <1079.4> on Temperature Mapping for the Qualification of Storage Areas became official, and it is the fourth part of USP General Chapter <1079> on Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products, which also includes: USP General Chapter <1079.1> on Storage and Transportation […]
The new Generic Drug User Fees for FY 2025 have been published (see Federal Register Notice here) and, with ANDA submission rates dipping, fees for submission of new ANDAs are soaring. The individual ANDA submission fee will be going up by $69,467 next year. Remember that October 1st (the beginning of FY 2025) is right around the […]
Dealing with different product requirements is often difficult, especially when the regulation office or center may differ as well. Over the years, individual post-approval change requirements have been scattered in documents from different centers and, if you have a good enough memory, then maybe you picked the right reporting requirement based on the product and […]
In pharmaceuticals, maintaining product quality and safety is paramount. Visual inspection plays a vital role in detecting particulate matter and/or container/closure defects, though it may fall short in pinpointing the root cause of defects or material origins. To fortify visual inspection programs effectively, a comprehensive risk assessment serves as the foundational pillar. This blog delves […]
The Office of Generic Drugs updated its list of the Competitive Generic Therapy (CGT) designation products that have been approved to date (here). There have been 312 products granted this designation since the start of the program, with the first application approved to gain CGT 180-day exclusivity under 506H of the Federal Food, Drug, and […]
Looks like the heat of July did not put a crimp in the OGD’s approval actions, at least through mid-month! As of the posting on July 16, 2024, the OGD has issued 39 full-approval actions and 8 tentative-approval actions a total of 47, for what will be (if the approval actions continue at this rate) a very […]
With the recent news of cuts in FDA funding (most recently reported by Zachary Brennan in an Endpoints News story entitled, “House Committee Raises Concerns on CDER-CBER Misalignment Amid 2025 Funding Markup” (here, subscription required), the question of FDA being asked to do more must be asked, as it now appears it will have to […]
May was a good month for the OGD in terms of approval actions and a few other statistical parameters. The OGD issued 71 final-approval actions and 13 tentative-approval actions in May 2024. While I was off in my estimation of unofficial actions by one on the approvals (72) and tentative approvals (12) (see the blog […]
June 2024 saw 49 full-approval actions and 12 tentative-approval actions for a total of 61 approval actions. If these figures hold, June will tie with March for the lowest number of total approval actions in a month. With May standing at a strong 84 unofficial approval actions, this up-and-down month-by-month scenario appears to be the […]
