Aiming to facilitate consultations for and submissions of an animal food additive petition (FAP) or a notice concluding that a substance is generally recognized as safe (GRAS) for its intended use in animal food, FDA released final guidance, with recommendations for:
- submissions to investigational food additive (IFA) files,
- use of foreign data in a submission,
- circumstances for the submission of study protocols,
as well as an explanation of FDA’s IFA submission review process and best practices for communication between FDA and stakeholders.
EAS toxicology team assists the human and animal food industry with preparation of submissions to FDA including facilitating pre-meetings with Agency, study design and monitoring, data assessment and preparation of submissions to the FDA.
Contact Us to discuss your product development questions and learn more about EAS solutions.