U.S. Food & Drug Administration (FDA)

by Matthew R. Bailey Originally Published 6:30 a.m. ET April 17, 2020 | Updated 7:06 a.m. ET April 17, 2020

Scientists are working on dozens of potential treatments and vaccines for the novel coronavirus and the disease it causes, COVID-19. Virtually all of them have one thing in common — they’re the product of animal

FDA has recently announced it is relaxing its enforcement of telemedicine for veterinarians under two federal provisions:  (1) when prescribing extralabel drug use; and (2) when prescribing medicate feed pursuant to the Veterinary Feed Directive.  Both generally require an initial physical examination of animals prior to such prescription.

FDA only enforces certain regulations governing a

Since we first published “FDA Continues Proposed Extra-Statutory Authority Over Compounded Animal Drugs,” a number of impacted stakeholders have been expressing concern about the intended and unintentional consequences of FDA’s current approach.

First, as a result of widespread concern about the proposed guidelines, FDA will be extending the time to comment, previously scheduled

On November 25, 2019, FDA posted 15 warning letters from the Center for Food Safety and Applied Nutrition (CFSAN) or the Center for Drug Evaluation and Research (CDER) stating that certain products containing CBD were illegally labeled as dietary supplements and in many cases were also: unapproved new drugs, misbranded drugs, adulterated human foods, and

Without clear statutory authority, FDA has proposed to expand its legal authority over veterinarians and veterinary compounding pharmacies in its newly released “Revised Draft Guidance on Compounding Animal Drugs from Bulk Drug Substances,” (#256) as announced on November 19, 2019.

FDA continues to describe the use of certain compounded medications for animals as violations of

Beef producers and packers have been required for years to “identify hazard points and critical points during beef slaughtering, which is a necessary first step toward developing a hazard analysis and critical control point system to control meat contamination by Escherichia coli O157:H7.”  See R. Guyon, et. al, Hazard Analysis of Escherichia coli O157:H7 Contamination

On October 30, 2018, the U.S. Food and Drug Administration “announced the Plant and Animal Biotechnology Innovation Action Plan to outline the key priorities the agency will pursue to support innovation in plant and animal biotechnology while advancing the agency’s public health mission. The overall goal of the action plan is to ensure the safety

As previously described, FDA has updated its Draft Guidance for Industry, #120, regarding the Veterinary Feed Directive Regulation.

The intersection of federal and state law impacted by this regulation is interesting.

Specifically, what is the impact to a veterinarian when the Veterinarian-Client-Patient relationship as defined by the relevant state law (governing that veterinarian’s license)

FDA recently released an edited version of its previously released guidance on the Veterinary Feed Directive Regulation fashioned as questions and answers.  (See Guidance #120).

Some of the edited and added Q&A will be discussed in future blogs, but the list of the edited and newly added questions, delineated in the table of

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