AHI Comments About Alternative Approaches in Clinical Investigations for New Animal Drugs

July 16, 2019 – AHI participated in the FDA Center for Veterinary Medicine’s public meeting about alternative approaches in clinical investigations for new animal drugs. 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. 

A call for action on alternative approaches in clinical investigations was included in the 4th Animal Drug User Fee Act of 2018 (ADUFA), which was signed into law by President Trump in August 2018. This meeting reflects congressional interest in supporting innovative clinical investigational approaches aimed at bringing new animal medicines to market.

Read AHI’s general comments here…