Guidance on CMC Section of Animal Drug Apps

Federal Register Notice: FDA is making available a draft guidance for industry entitled Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications. In order to improve the process for submission and CMC information for animal drugs, CVM has developed a series of questions that focus on the critical scientific and regulatory issues and pharmaceutical attributes essential for ensuring the quality of new animal drug substances and products. The Question-based Review provides a general framework for original CMC submissions to investigational new animal drug files, generic investigational new animal drug files, new animal drug applications, abbreviated new animal drug applications, conditional approval of applications for conditional approval, and veterinary master files. To download this guidance, click here. To view this notice, click here.