May 14, 2019

The U.S. Food and Drug Administration’s Center for Veterinary Medicine is announcing today it will hold a public meeting on July 16, 2019, to gather input about alternative approaches in clinical investigations for new animal drugs to help ensure the continued safety and effectiveness of new animal drugs. The meeting will be held at John Hopkins University – Montgomery County, 9601 Medical Center Drive, Rockville, Maryland 20850, and may be expanded to part or all of July 17, 2019. Please visit FDA’s public meeting web page for updates.

The meeting will focus on potential alternative approaches in clinical investigations, including incorporating complex adaptive and other novel investigation designs, data from foreign countries, real-world evidence (including ongoing surveillance activities, observational studies, and registry data), biomarkers, and surrogate endpoints into proposed clinical investigation protocols and applications for new animal drugs.

The meeting will also focus on the use of data from studies conducted outside the U.S. to support a food additive petition. Currently, the FDA can accept data from studies conducted outside the U.S. to support a new animal drug application, provided the applicant demonstrates that the data are adequate under applicable standards to support approval. The FDA can also accept data from studies conducted outside the U.S. to support a food additive petition. While the regulatory standards for approval differ between animal drugs and animal food additives, data from foreign countries can be used to support either approval if the data meet the appropriate regulatory standards. The FDA is requesting public comment on a series of questions related to the use of foreign data to support both animal drug and animal food additive petition approvals.

The FDA is seeking information and comments on these topics from a broad range of stakeholders, including representatives of regulated industry, consumer groups, academia, veterinarians, and food producers.

The input will inform the development of guidance addressing the incorporation of alternative approaches into proposed clinical investigation protocols and applications for new animal drugs. FDA guidance on these topics will help provide clarity to animal drug sponsors as they prepare data submissions related to new animal drug products for agency evaluation and review, as part of the FDA’s new animal drug approval process. Public input on the use of data from studies conducted outside the U.S. to support a food additive petition will inform a separate guidance about the investigational food additive process.  

This public meeting and the development of guidance is required under section 305 of the Animal Drug and Animal Generic Drug User Fee Amendments of 2018.

For more information and to register, visit CVM’s meeting web page.

Additional Information:

• Public Meeting: Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs