Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs; Public Meeting; Request for Comments

摘要

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled "Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs." This public meeting and request for comments is intended to support FDA guidance development as required by the Animal Drug and Animal Generic Drug User Fee Amendments of 2018. The topics to be discussed will inform the development of guidance to assist sponsors in 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 under the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is seeking comments from stakeholders, including representatives of regulated industry, consumer groups, academia, veterinarians, and food producers.