- Yesterday, FDA’s Center for Veterinary Medicine (CVM) released the results of its evaluation of the Food Additive Petition (FAP) and GRAS Notification (GRN) review programs. The evaluation was launched in August 2024 and included soliciting public comments, conducting 14 external engagement sessions, holding internal CVM staff interviews, and analyzing feedback across program areas.
- CVM announced that it is implementing “several targeted process improvements” that aim to “deliver faster, more predictable outcomes for submitters.” These are summarized in the evaluation summary and include the following commitments:
- Improve clarity on disclosure and confidentiality requirements during meetings with notifiers.
- Update internal best practices to improve consistency and reduce reviewer burden.
- Implement earlier review timelines which will communicate any issues to notifiers earlier in the process.
- Create a second amendment opportunity during the GRN review process.
- Publish a Program Policy and Procedures Manual (PPM) with a GRN timeline.
- Expand data flexibility, including extrapolation of data across species, where appropriate.
- Collaborate with the International Cooperation for the Convergence of Technical Requirements for the Assessment of Feed Ingredients (ICCF) to improve alignment with international standards.
- CVM published PPM 1244.3425: Animal Food Generally Recognized as Safe (GRAS) Notice Evaluation Timeline to address commitment #5. The document is intended to turn an informal understanding on the review timeline into a publicly available commitment. The timeline in the document includes a 30-day pre-filing evaluation, a response letter within 215 days of filing if there is no second amendment, and a response letter within 270 days of filing if there are two amendments (each amendment corresponds to a round of CVM questions). Therefore, the document contemplates that all reviews will be completed within a maximum of 300 (calendar) days (30 days pre-filing + 270 days post-filing).