The Center for Veterinary Medicine (CVM)’s Office of New Animal Drug Evaluation (ONADE) will now be two separate offices [1]:
- Office of New Animal Product Evaluation (ONAPE)
- Office of Generic Animal Drugs (OGAD)
The restructuring was approved on July 22, 2024 by the Secretary of Health and Human Services. This change will allow the FDA to be more efficient and will allow ONAPE to focus on new, developing products. In more recent years, there has been an overwhelming amount of generic animal drugs coming to market.
On Thursday, March 30, 2023, the Subcommittee on Health held a hearing to consider reauthorization of the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA). Stephanie Batliner, the Chair of the Generic Animal Drug Alliance testified that “In 2021, generic animal drug sponsors overall made nearly twice as many submissions than in 2017, however the number of generic animal drug approvals per year has remained relatively stable” [2]. In order to keep up with the boom of new generic drug submissions, the FDA has separated ONADE into ONAPE and OGAD to address the demand.
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[1] FDA (2024), FDA Reorganizes Animal Drug Evaluation Structure to Better Align Innovative Products, Generic Drugs,Retrieved on 22 October 2024 from: https://www.fda.gov/animal-veterinary/cvm-updates/fda-reorganizes-animal-drug-evaluation-structure-better-align-innovative-products-generic-drugs
[2] GADA (2023) Testimony of Stephanie Batliner Chair Generic Animal Drug Alliance Before the U.S. House Committee on Energy & Commerce Subcommittee on Health, Retrieved on 22 October 2024 from: https://www.congress.gov/118/meeting/house/115630/witnesses/HHRG-118-IF14-Wstate-BatlinerS-20230330.pdf
