Real World Data for Animal Drugs, Too: New FDA Guidance Provides Tips
(Thursday, October 21, 2021)
Just like human drugs, animal drugs can also be approved based on real world evidence available from veterinary records. However, there are several issues to be considered for creating sufficient supportive real world data for animal drug approval applications. A new FDA guidance released this week discusses the nuances of the real world data (RWD) expected for veterinary drugs and the real world evidence (RWE) generated from it, and it looks very similar to the advice provided for using RWD/RWE for human drugs. The guidance provides several considerations for data collection, cleaning, analysis, and presentation for productive interactions with the FDA regarding new drugs and new applications for previously approved drugs. For the RWD, FDA expects at the minimum a written description of the protocols used for data collection and transformation to databases, and procedures used to ensure completeness, consistency, and accuracy of data collected. RWE generated using well controlled methods can be used to justify a dose and dosage regimen, indications, develop historical, external, or concurrent controls, justify sample sizes for clinical trials, define appropriate enrollment criteria, and provide the rationale for the endpoints in clinical studies with new veterinary drugs. FDA would accept RWE generated such way for both INADA applications (investigational new animal drug applications) or to provide substantial evidence of effectiveness for an original or supplemental New Animal Drug Approval (NADA) applications. The guidance establishes almost identical expectations from RWD/RWE for animal drugs as have been described previously for human drugs. In general, FDA is consistent in its assertion for the quality of data requirements for all products intended for humans or animals.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC