The Biosimilar User Fee Program has announced the new FY 2025 fee schedule in the pre-publication of the Federal Register Notice (here). The base fee amount for the BsUFA program for FY 2025 is $51,058,823, which is adjusted for inflation (this year is calculated at 4.1881%); along with factoring in other required estimated expenses, this results in […]
Yesterday’s pre-publication Federal Register Notice (here) announced the Prescription Drug User Fees Act (PDUFA) program fees to be charged to fee-paying new drug applications for FY 2025. As you will note from the chart below, the application fees increased, but the program fee decreased. It is interesting that the magnitude of the application fee increases were […]
The FDA announced the Animal Drug User Fees (here) as well as the Animal Generic Drug User Fees (here). Unlike the Animal Drug User Fees for FY 2025, which are all are decreasing, the Animal Generic Drug User Fees are all increasing for FY 2025 with exception of the Generic New Animal Drug Product Fee, […]
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 […]
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 […]
