Meeting

Event Title

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

July 16, 2019

Date:: July 16, 2019
Time:: 8:30 AM - 5:00 PM ET

Organized By:: Organizer

Center for Veterinary Medicine

The FDA’s Center for Veterinary Medicine conducted a public meeting to gather input about alternative approaches in clinical investigations for new animal drugs, 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 also focused 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 meeting included four sessions that focused on the following topics: (1) complex adaptive and other novel investigation designs; (2) data from foreign countries; (3) real-world evidence; and (4) biomarkers and surrogate endpoints. Within each session and following all sessions there was be an opportunity for public comment.

The FDA is seeking information and comments 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 the alternative approaches listed above into proposed clinical investigation protocols and applications for new animal drugs. 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. To facilitate the development of these guidance documents, the FDA has questions on the meeting topics we ask you to consider.

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

Dates:

July 16, 2019

Time:

8:30 a.m. to 5:00 p.m.

Location:

Johns Hopkins University – Montgomery County
9601 Medical Center Drive
Rockville, MD 20850

Meeting Information:

Meeting Transcript

Slide Presentation: Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs

Webcast Recording:

A webcast recording is available in four distinct segments. Each segment is in order based on the agenda. The audio quality during the first session is less than optimal. The audio quality improves in later sessions. Please refer to the transcript, when available, for the inaudible portions.

Opening Remarks/Session 1: Complex Adaptive and Other Novel Investigation Designs
Session 2: Real World Evidence
Session 3: Biomarkers and Surrogate Endpoints
Session 4: Data from Foreign Countries/Closing Remarks

Submitting Comments:

FDA established a docket for public comment. The docket number is FDA-2019-N-2281. Submit either electronic or written comments on this public hearing by September 16, 2019. Please note that late, untimely filed comments will not be considered. The Regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 16, 2019. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Additional Information:

Event Materials

Title	File Type/Size
Agenda: Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs	pdf (92.91 KB)
Biographies of Speakers and Panelists: Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs	pdf (84.17 KB)