Animal Drug and Animal Generic Drug User Fee Amendments of 2023

Bill 118 hr 1418, also known as the Animal Drug and Animal Generic Drug User Fee Amendments of 2023, is a piece of legislation currently being considered by the US Congress. The bill aims to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and make improvements to the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA).

The main purpose of this bill is to ensure the safety and effectiveness of animal drugs by providing the Food and Drug Administration (FDA) with the necessary resources to review and approve new animal drugs in a timely manner. The bill also aims to enhance communication and collaboration between the FDA and stakeholders in the animal drug industry.

Some key provisions of the bill include increasing user fees for animal drug and animal generic drug applications, establishing performance goals for the FDA in reviewing these applications, and requiring the FDA to report on its progress in meeting these goals. The bill also includes provisions to improve the transparency and accountability of the FDA's regulatory processes for animal drugs. Overall, Bill 118 hr 1418 seeks to promote the development and approval of safe and effective animal drugs, while also ensuring that the FDA has the resources and tools necessary to fulfill its regulatory responsibilities in this area.