FDA’s Center for Veterinary Medicine (CVM) recently announced the upcoming expiration of its longstanding Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO). This MOU—which has...more
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
There are plenty of attractive reasons to launch or buy a veterinary practice in Utah. The beehive, the official emblem of Utah, is a symbol of diligence and perseverance, and the state’s hard work and industry has paid off:...more
Exciting updates from the National Veterinary Law Group at Mandelbaum Barrett PC! Our newest newsletter has arrived, brimming with invaluable insights tailored for the veterinary industry. Discover informative articles...more
The Drug Enforcement Administration (DEA) recently issued a new regulation codifying provisions of the Veterinary Medicine Mobility Act of 2014 (VMMA). The VMMA, which was signed into law in 2014, allows a veterinarian to...more
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
Exciting news from the National Veterinary Law Group at Mandelbaum Barrett PC! Our latest newsletter is here, and it’s packed with valuable insights for the veterinary industry. In this issue, you’ll find informative articles...more
On February 15, 2023, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) and the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM)...more
Last month our client alert covered the increasing popularity of cannabis products for pets in the face of regulatory uncertainty. This month we highlight recent California legislation that protects veterinarians who...more
The EU Commission opened this afternoon the public consultation on the EU general pharmaceuticals legislation on medicines for human use. This initiative is part of the EU Pharmaceutical Strategy for Europe and calls on...more
A bill in New Jersey that would have interfered with rabies testing of domestic companion animals has been amended to remove the potentially dangerous and unneeded obstacles to timely testing...more
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
Market research shows that more than half of US households keep pets, and this number is likely to increase as people continue to be isolated, stay at home, or seek the mental and physical benefits associated with pet...more
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
Patent term extension (PTE) is available under the 1984 Drug Price Competition and Patent Restoration Act, also known as the Hatch-Waxman Act (The Act). The Act allows the extension of the term of a patent claiming a product...more
On March 24, 2020, the US Food and Drug Administration (“FDA”) issued Guidance[1] suspending the enforcement of certain veterinarian-client-patient relationship (“VCPR”) requirements to help veterinarians provide animal...more
Update: On September 24, 2021, the Federal Court of Appeal allowed the Minister’s appeal of this decision and remitted the matter to the Federal Court for redetermination of several issues: Canada (Health) v Elanco Canada...more
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
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
The Queen's Speech, which set out the government's proposed plan for new legislation, included a new "Medicines and Medical Devices Bill". The government's background briefing describes the purpose of the Bill as ensuring...more
September 21, 2019 marked the second anniversary of the certificate of supplementary protection (CSP) regime in Canada. CSPs provide an additional term of patent-like protection of up to two years. In our first anniversary...more
According to the 2017-2018 American Veterinary Medical Association’s Pet Ownership and Demographic Sourcebook, approximately 71.5 million U.S. households own at least one pet, 38% of which are dogs. There is also a large...more
On April 2, 2019, U.S. Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, M.D., and Deputy Commissioner for Policy, Legislation and International Affairs, Anna Abram, released a statement on the status of FDA’s...more
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
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