Day: March 23, 2023

This week FDA updated its Medical Foods guidance to clarify and expand on its previous guidance from 2016. The main update is regarding the requirement for allergen warning on medical food labels but there are several other pointers in the guidance about medical foods to answer common questions from consumers and industry alike. Medical foods … Read more

FDA allows animal drug approvals based entirely on published literature provided the selected publications adequately justify the specific claims in the market approval application and meets well-established scientific quality standards. Published literature lacks several quality standards essential for regulatory acceptance as sole evidence. FDA’s latest guidance on the topic lists those challenges and suggests ways … Read more