News & Analysis as of

Pharmaceutical Industry Food and Drug Administration (FDA) Animal Health

Alston & Bird

FDA Proposes to Overhaul Labeling Requirements for Approved or Conditionally Approved New Animal Drugs

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Nearly five decades after the FDA last reorganized animal drug labeling regulations, the agency has released a proposal to revise the requirements for the content and format of labeling for approved or conditionally approved...more

Hogan Lovells

FDA warns animal drug companies over unapproved antimicrobials, identifying “public health concerns”

Hogan Lovells on

In December 2023, the U.S. Food and Drug Administration (FDA) issued nine Warning Letters for the manufacture and distribution of unapproved over-the-counter (OTC) antimicrobial animal drugs for use in aquarium fish and...more

Stevens & Lee

FDA Guidance on Drug Compounding for Veterinarians and Pharmacists

Stevens & Lee on

The Guidance published in the Federal Register last April for “veterinarians, State-licensed pharmacies, and Federal facilities” regarding compounding animal pharmaceuticals will take effect April 2023. The guidance focuses...more

Fox Rothschild LLP

FDA Issues Guidance Recommending That Animal-Approved Over-The-Counter Medically Important Antimicrobial Drugs Are Required To Be...

Fox Rothschild LLP on

FDA recently published Guidance #263 titled, “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to...more

Fox Rothschild LLP

Veterinary Medicine, Pet Products And Cannabis

Fox Rothschild LLP on

As a veterinarian, if a pet-owner comes to you with questions or concerns about the safety of hemp or CBD infused pet products, are you prepared to navigate the conversation? Practicing veterinarians are subject to the...more

Fox Rothschild LLP

Annual Conference Of The Food And Drug Law Institute

Fox Rothschild LLP on

I attended the Annual Conference of the Food and Drug Law Institute held in Washington, D.C. on May 2-3, 2019, a truly informative and well-orchestrated conference that included sessions discussing all manner of issues facing...more

McGuireWoods LLP

Fireworks for Animal Drug Compounding at ACI’s Inaugural Animal Health and Veterinary Drugs and Therapeutics Conference-Part Two...

McGuireWoods LLP on

The second day began with a deep dive into the development of advanced biological drugs for animal use. David Brake, Ph.D., Founder and Principal, BioQuest Associates, LLC, helped explain the split between USDA and FDA...more

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