FDA Issues Final Guidances to Help Facilitate the Development of New Animal Drug Submissions - Healthy Food Deals

If your email program has trouble displaying this email, view as a webpage. FDA Issues Final Guidances to Help Facilitate the Development of New Animal Drug Submissions The FDA has issued four final guidance documents to promote innovative approaches to animal drug development: final guidance for industry (GFI) #265, "Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs"; final guidance for industry (GFI) #266, "Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs"; final guidance for industry (GFI) #267, "Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs"; and final guidance for industry (GFI) #268, "Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs." The FDA received comments on the draft guidance documents and those comments were considered as the guidances were finalized. Editorial changes were also made to the final versions to improve clarity. You are subscribed to updates from FDA's Center for Veterinary Medicine.

Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA