Animal Drug User Fee Act Re-Authorization

The Animal Drug User Fee Act (ADUFA), amends the Federal Food, Drug, and Cosmetic Act (FFDCA) and authorizes FDA to collect fees for certain animal drug applications.

The AVMA supports user fees for new animal drug applications only if such fees are directed toward enhanced review and approval of animal drug products. An effective and efficient animal drug approval process is essential, both to the health and well-being of animals and to overall public health. From the long-recognized threats of zoonotic diseases, such as food borne bacteria that can cause illness in people, the need to protect public health by protecting animal health has never been more important.

Information on the Animal Drug User Fee Act:

  • 2007 ADUFA items:
    • AVMA Council on Biologic and Therapeutic Agents (COBTA) letter to FDA on new animal drug application funds stifling drug development by small companies 
    • FDA Reponse to COBTA letter

Information on the Animal Generic Drug User Fee Act (AGDUFA)