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 […]
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 […]
The FDA has just revised a guidance titled, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers” (here) which says: “This revised draft guidance, when finalized, will describe FDA’s current thinking on common questions firms may have when voluntarily addressing misinformation about or related to their approved/cleared medical products. This guidance revises and […]
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 […]
In a recent landmark decision, the Supreme Court struck down what is known as the Chevron decision, a 1984 case that basically gave federal agencies deference in how to interpret statutes that may be somewhat ambiguous or not completely clear. This deference was not, of course, absolute (as we will see later), but, basically, under […]
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 […]
The FDA released a draft guidance titled Considerations in Demonstrating Interchangeability With a Reference Product: Update (here), which acknowledges the FDA’s continued evaluation of the biosimilar data collected to date and worldwide acknowledgement that if a biosimilar is approved using the analytical methods required for approval, including appropriate in vitro testing, there should be no […]
After two stellar months, the OGD approvals (at least through mid-June) appear to have slowed down a bit, with 31 full-approval actions and six tentative-approval (TA) actions reported through June 16th (here). While there is still time for the approval pace to pick up during the latter part of June, with 37 total approval actions […]
