Issue Date: October 6, 2021
Issued by: Center for Veterinary Medicine
Topic(s): Premarket, Investigational New Animal Drug (INAD), New Animal Drug Application (NADA), Target Animal – Effectiveness
Status: Final
CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs
This guidance describes how CVM intends to evaluate real-world data and real-world evidence in submissions to CVM to demonstrate substantial evidence of effectiveness for new animal drug applications or a reasonable expectation of effectiveness for applications for conditional approval of a new animal drug. It also provides information about how sponsors may obtain feedback from CVM on technical issues related to the use of real-world data and real-world evidence before the submission of an application.
Download the Guidance Document
