FDA Issues 4 Animal Drug Development Guidances

FDA has published four draft guidances to help facilitate the development of new animal drug products. Center for Veterinary Medicine director Steven Solomon says the publication “fulfills part of FDA’s Animal Drug and Animal Generic Drug User Fee Amendments of 2018 to issue guidance that assists animal drug manufacturers in addressing the incorporation of alternative approaches into proposed clinical investigation protocols and applications for new animal drugs.”

If finalized, the drafts will help encourage animal drug sponsors to use innovative approaches as they prepare data submissions for new animal drug products for agency evaluation and review, Solomon says.

The guidances are: 

•          Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs;
•          Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs;
•          Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs; and
•          Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs.