Nancy Halpern D.V.M. on Food and Drug Administration (FDA)

VFDs and the Veterinary Shortage

In April of 2024, the United States Food and Drug Administration (FDA) finalized new Guidance for Industry (GFI) #120: Veterinary Feed Directive Regulation Questions and Answers to inform industry stakeholders and small...more

7/9/2024 / Animal Drugs , Animal Food , Animal Health , Food and Drug Administration (FDA) , Veterinarians , Veterinary Products

Data Collection of Antimicrobial Use In Animals

Concerns about the potential for antibiotic resistance started when they were first introduced as life-saving tools in human medicine. Despite such concerns, the importance of these tools for public and animal health have...more

2/23/2022 / Animal Health , Antimicrobials , Data Collection , Food and Drug Administration (FDA) , Infectious Diseases , USDA , Veterinarians

FDA Issues Guidance #263 Recommending That Animal-Approved Over-The-Counter Medially Important Antimicrobial Drugs Are Required To...

FDA has continued to exercise its authority, via guidance documents, which FDA says, while not legally enforceable, represent the agencies current thinking on the topic. To further the judicious use of medically important...more

7/29/2021 / Animal Health , Antimicrobials , Farmers , Food and Drug Administration (FDA) , Over The Counter Drugs (OTC) , Secretary of Agriculture , Veterinarians

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

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

6/24/2021 / Animal Health , Antimicrobials , Food and Drug Administration (FDA) , Labeling , Over The Counter Drugs (OTC) , Pharmaceutical Industry , Veterinarians

California Proposes Regulations Governing Compounding In A Veterinary Premises

The California Veterinary Medical Board has proposed amending the California Code of Regulations to clarify the process for veterinarians to compound drugs in a veterinary office for the treatment of an animal patient. As...more

8/6/2020 / Animal Drugs , Animal Health , Employee Training , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , New Regulations , Recordkeeping Requirements , Veterinarians , Veterinary Products

COVID 19 Update Telemedicine: Enhanced Tools Available For Veterinarians

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...more

3/31/2020 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Telemedicine , Veterinarians

Update To FDA’s Guidance #256 On Compounded Animal Drugs

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...more

2/25/2020 / Animal Drugs , Animal Health , Food and Drug Administration (FDA) , Veterinarians , Veterinary Products

CBD Product Sellers Beware: FDA Issued Warning Letters Claiming Certain CBD Products Are Unapproved New Human And Animal Drugs

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...more

12/31/2019 / Cannabidiol (CBD) oil , Dietary Supplements , Food and Drug Administration (FDA) , Hemp

FDA Continues Proposed Extra-Statutory Authority Over Compounded Animal Drugs

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...more

12/3/2019 / Animal Drugs , Animal Health , Drug Compounding , Food and Drug Administration (FDA) , Veterinarians , Veterinary Products

Animal Biotechnology-The Way Forward

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...more

5/9/2019 / Animal Health , Biotechnology , Food and Drug Administration (FDA) , Popular , USDA

Annual Conference Of The Food And Drug Law Institute

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

5/6/2019 / Animal Health , Food and Drug Administration (FDA) , Pharmaceutical Industry

FDA’s Revised Veterinary Feed Directive Part II

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....more

4/3/2019 / Animal Drugs , Animal Food , Animal Health , Food and Drug Administration (FDA) , Veterinarians , Veterinary Products

FDA Publishes Revised Draft Guidance #120 (Veterinary Feed Directive)

FDA recently released an edited version of its previously released guidance on the Veterinary Feed Directive Regulation fashioned as questions and answers. Some of the edited and added Q&A will be discussed in future...more

4/2/2019 / Animal Food , Animal Health , Food and Drug Administration (FDA) , Veterinarians , Veterinary Products

A Potpourri Of Updates About USDA And FDA

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...more

12/14/2018 / Animal Drugs , Biotechnology , Food and Drug Administration (FDA) , USDA

The Use And Governance Of Veterinary Clinical Studies

Clinical trials are commonly used during the development of drugs studied for approval by FDA for the use in animals. Similar use in veterinary medicine has been increasing, but there are a number of interesting issues not...more

11/28/2018 / Animal Health , Clinical Trials , Food and Drug Administration (FDA) , Veterinarians

The Care Of Small Ruminants In The Absence Of FDA-Approved Medications

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,...more

11/14/2018 / Animal Drugs , Animal Health , Food and Drug Administration (FDA) , Veterinarians , Veterinary Products

Help For Animal Owners And Businesses Affected By Recent Hurricanes

State Departments of Emergency Management prepare and respond to natural disasters by implementing the orchestrated emergency response plans, which state, federal and non-profit partners help develop over the years. These...more

10/15/2018 / Animal Health , Food and Drug Administration (FDA) , Natural Disasters , USDA , Veterinarians

Food Animal Veterinarians, Producers And Feed Mills Should Prepare For Enhanced FDA Enforcement.

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...more

9/17/2018 / Farm Animals , Food and Drug Administration (FDA) , Food Safety , Food Supply

Why Pet Owners Are Understandably Confused About Pet Medications.

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...more

11/13/2017 / Animal Drugs , Animal Health , Food and Drug Administration (FDA) , Veterinarians , Veterinary Products

Nancy Halpern D.V.M.

Fox Rothschild LLP

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