Postapproval Changes to Drug Substances Draft Guidance for Industry; Availability

The ANIMAL HEALTH INSTITUTE (AHI) submits these comments to Docket No. FDA-2018-D-3151 Postapproval Changes to Drug Substances. AHI is the national trade association representing manufacturers of animal health products -- the pharmaceuticals, biological products and feed additives used in modern food production, and the medicines that keep livestock and pets healthy. AHI member companies represent the majority of animal pharmaceuticals and animal insecticides, as well as serving a significant segment of the world market. We respectfully submit the below comments and questions for your consideration. General comments are provided first followed by comments referencing specific sections or text. AHI again thanks you for your time and consideration of these comments.