Some happenings at USDA and FDA that may impact your business are noteworthy.

On November 16, 2018 FDA released for public comment “proposed research to validate an alternative approach for bioequivalence studies for certain animal drugs.”

Bioequivalence studies are required before drugs are approved by FDA (for humans or animals) as safe and efficacious.

The

The Food Animal Residue Avoidance Databank (FARAD) recently provided guidance to small ruminant producers and their veterinarians in an article titled “Extralabel drug use (ELDU) in small ruminants” in JAVMA, Vol 253, No. 8, Oct. 15, 2018, pp 1001-1009.

FARAD is a university-based national program that serves as the primary source for scientifically-based recommendations

As part of its Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings—just released—FDA announced that it plans to shift from “educating” food animal veterinarians and producers about the 2016 Veterinary Feed Directive (VFD) to “ensuring compliance with the . . . regulation to further ensure the safety of animal and human health.”  In

FDA’s recent announcement that it is “withdrawing draft Guidance for Industry (GFI) #230, ‘Compounding Animal Drugs from Bulk Drug Substances’” reminded me that pet owners can become confused about what type of medications are available for treating their pets.  For example, while serving on the New Jersey State Board of Veterinary Medicine, I