Since the retirement of CVM Guidance for Industry (GFI) #42 “Animal Drug Manufacturing Guidelines – Series of Four Guidelines,” which was withdrawn in October 2019, the animal health industry has been anticipating guidance from the CVM on these topics. The first of four anticipated guidance documents was issued on March 18, 2024 as a draft (here), and […]
On September 30, 2023, the Animal Drug and Animal Generic Drug User Fee Amendments of 2023 were signed into law as part of H.R. 5860. The amendments reauthorize the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) programs administered by the U.S. Food and Drug Administration until 2028. But not […]
In a recent issue of a veterinary journal, vaccines for bees (for American Foul Brood – AFB) made the headlines. Veterinarians would oversee administering the vaccine and possibly in “compounding” the vaccine for specific queen bees. Honeybees are food animals because they produce honey for human consumption and because they have a role in crop […]
In the prepublication of the Federal Register this morning, the FDA announced the Animal Drug User Fee Rates (here) and the Animal Generic Drug User Fee Rates (here). Some of the fees increased significantly while others decreased. Fee variations are based on the projected number of applications, establishments, and products, as well as inflationary calculations. […]
In a series of four Federal Register Notices issued today, the FDA announced the fee structures for the last four UFAs for Fiscal Year 2020. It is no surprise that the PDUFA fees are the highest overall in total, with well over $1 billion in potential collections. The fees for each of the programs are […]
