FDA Releases Guidance on Veterinary Medicines

The Food and Drug Administration (FDA) has announced the availability of industry guidance concerning drugs for veterinary care. The guidance provides “recommendations on what documentation to submit to support the CMC [Chemistry, Manufacturing, and Controls] information for fermentation-derived intermediates, drug substances, and related drug products for veterinary medicinal use.”

Noting that a variety of products are manufactured from fermentation
processes, such as “competitive exclusion products” that consist of one or more
microorganisms intended to prevent harmful bacteria like Salmonella from
colonizing, FDA has requested comments on the guidance at any time. See
Federal Register, March 8, 2012.