Public Meeting: Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs - 07/16/2019 - 07/16/2019
- July 16, 2019
- July 16, 2019
- Organized By:
The FDA’s Center for Veterinary Medicine will conduct 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 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 meeting is expected to include four sessions that focus 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 will 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.
This web page will be updated as meeting specifics and materials are developed.
July 16, 2019
The meeting may be expanded to part or all of July 17, 2019.
8:30 a.m. to 5:00 p.m.
If warranted, a half- or full-day session may be held on July 17, 2019.
Johns Hopkins University – Montgomery County
9601 Medical Center Drive
Rockville, MD 20850
To attend the meeting in person:
Registration is required for those who wish to attend the meeting in person. Seating will be on a first-come, first-serve basis for those who do not wish to speak or present. Onsite registration on the day of the meeting will be provided based on space availability. The meeting will also be webcast.
Provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.
To speak or present at the meeting:
Speakers/presenters must attend the meeting in person and register by June 24, 2019.
To register as a speaker/presenter, follow the registration instructions above. With the registration information, please indicate if you wish to present during a public comment session or participate in a specific session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. If you wish to submit information in support of your presentation or to submit presentation material, please submit the information directly to the docket by June 24, 2019.
Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin and will select and notify participants by July 1, 2019. The approximate time for each presenter will not exceed 10 minutes. No commercial or promotional material will be permitted to be presented or distributed at the public meeting.
To attend the meeting by webcast:
Further information will be provided here when available.
A transcript of the meeting will be available in the docket approximately one month after the meeting takes place.
In addition to providing input at the public meeting, stakeholders are invited to submit comments through the public docket. The public docket will close on August 17, 2019.