It was my pleasure this week to join my Brakke colleagues and many global animal health industry leaders in London for Kisaco’s Animal Health & Nutrition Technology and Innovation Conference.
The quality and quantity of presentations and conversations highlighted the strength of the animal health industry and its many innovation opportunities ahead.
A particularly refreshing presentation was a conversation facilitated by Kristin Peck, CEO of Zoetis, and Dr. Timothy Shell, Director of the FDA’s Center for Veterinary Medicine (CVM). Dr. Shell shared his vision for reforming the CVM’s animal health approval process, noting that FDA interactions will play a key role in determining how future innovations reach the market.
He touched on several proposed changes—cautioning these are not formal guidance and likely require 3–5 years to implement:
- Reducing average approval time from 10 years to 5 years
- Tripling MUMS approvals from 2 to 6 per year, with a voucher program for expedited review
- Extending conditional approval from 5 to 7 years for chronic diseases and including the CMC section
- Updating the user fee program to enable shorter reviews with applicable fees
- Evolving residue and toxicology regulations
- Leveraging foreign agency data and approvals, while addressing regulatory gaps within set timelines
- Utilizing AI to accelerate administrative processes
In closing, Dr. Shell stated that the CVM is evolving and encouraged companies never to pause or delay projects without first consulting the agency. This collaboration will support the timely introduction of valuable animal health products for pets and livestock.
Chuck Johnson DVM, MBA
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