Glossary

Center for Veterinary Medicines (CVM) 

The FDA's Center for Veterinary Medicine (CVM) is a branch of the U.S. Food and Drug Administration (FDA) that protects human and animal health by ensuring the safety and effectiveness of animal drugs, animal food (including pet food), and animal devices. CVM regulates these products to ensure they are safe for animals and that food from treated animals is safe for human consumption.  

Center for Veterinary Biologics (CVB) 

The Center for Veterinary Biologics (CVB) plays a vital role in regulating products that diagnose, prevent, or treat animal diseases. The CVB uses scientific information and regulatory processes to assure its customers that the veterinary biological products available for use are of high quality. It encourages open communication with stakeholders as new products and standards are developed. The CVB promotes the use of quality assurance processes that inherently result in the production of pure, safe, potent, and effective veterinary biologics and diagnostics. It provides strong leadership in the development and international harmonization of standards for veterinary biological products. 

Code of Federal Regulations (CFR) 

Title 21 Chapter I Subchapter E of the Code of Federal Regulations (CFR) covers regulations for Animal Drugs, Feeds, and Related Products. Administered by the FDA, this section (Parts 500-599) includes rules for animal food labeling, drug manufacturing, investigational new animal drugs, and medicated feed licenses.  

Compassionate Use

Compassionate use refers to the provision of an unapproved or experimental medication or medical device to a patient with a serious or life-threatening condition  

Conditional Approval (CNADA) 

FDA's Center for Veterinary Medicine (CVM) grants conditional approval to new animal drugs when a sponsor has demonstrated safety and manufacturing standards, and a reasonable expectation of effectiveness, but not yet the full "substantial evidence" required for full approval. This allows the sponsor to legally market the drug for a limited time (up to 5 years with annual renewals) while they gather the remaining effectiveness data for full approval.  

Emergency Drug Release (EDR, Canada) 

Health Canada’s Emergency Drug Release (EDR) program allows veterinarians to access unapproved or unavailable drugs to treat animals with serious or life-threatening conditions when conventional therapies have failed or are unavailable 

Emergency Use Authorization (FDA) 

The Emergency Use Authorization (EUA) authority allows the FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats, including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies. 

Expanded Access 

Expanded access, also known as compassionate use, is a pathway for patients with serious or life-threatening diseases to access investigational medical products (drugs, biologics, or medical devices) outside of clinical trials when no comparable or satisfactory alternative therapies are available.  

Expanded Authority 

The FDA can approve drugs for serious, unmet medical needs in animals under specialized circumstances. 

Extra-Label 

Extra-label drug use (ELDU) in veterinary medicine, also known as "off-label use," is the practice of using a drug in an animal in a manner not in accordance with its FDA-approved label directions.  

Food and Drug Administration (FDA) 

The FDA, or Food and Drug Administration, is a U.S. government agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and animal drugs, biologics, medical devices, the nation's food supply, cosmetics, and products that emit radiation. It's part of the Department of Health and Human Services.  

Future Use 

Health Canada's Special Access Program (SAP), which allows healthcare professionals to request non-marketed drugs for medical emergencies. You must submit a future-use form providing a valid reason, such as potential future emergency scenarios, rather than for a specific patient.  

Health Canada (HC) 

Health Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible and works to reduce health risks. 

Indexing 

An "indexed" animal drug, within the context of FDA regulations, refers to a new animal drug for a minor species that has been added to the FDA's Index of Legally Marketed Unapproved New Animal Drugs for Minor Species. This means the drug is not fully approved by the FDA but is legally marketed for specific uses in certain minor species. 

Informed Consent 

Informed consent is the voluntary authorization by a patient or research subject to undergo a medical intervention or participate in research after understanding the risks, benefits, and alternatives.

Informed Consent Form (ICF) 

A veterinary informed consent form is a legal document confirming that a pet owner authorizes a specific treatment or procedure after the veterinarian has explained the diagnosis, risks, benefits, costs, and alternatives. It serves as written evidence that the client was sufficiently informed to make a knowledgeable decision. 

Institutional Review Board (IRB) 

A veterinary institutional review board, often called a Veterinary Clinical Studies Committee (VCSC) or an Institutional Animal Care and Use Committee (IACUC), ensures research on animals is ethical and safe. These committees review study protocols, oversee the welfare of client-owned or laboratory animals, and verify informed consent for clinical trials.  

Investigational New Animal Drug (INAD) 

An Investigational New Animal Drug (INAD) is a drug intended for animal use that is in the approval pipeline but not yet approved by the FDA for general marketing in the U.S. INADs allow authorized researchers to legally use unapproved drugs to collect safety and efficacy data, typically supporting a New Animal Drug Application (NADA). 

Managed Entry 

Structured, strategic frameworks enabling access to new, innovative, or specialized treatments, often bridging gaps between regulatory approval and clinical availability. These programs, such as Managed Access Programs (MAPs), allow veterinarians to secure, import, or use advanced pharmaceutical products for animals, particularly in complex cases or when conventional therapies are insufficient.

Managed Access Program (MAP) 

Managed access programs (MAPs) are mechanisms that allow patients with unmet medical needs to access investigational or unapproved medicines, often when clinical trials are not an option. 

Named Patient 

A named patient program (also known as a named patient supply or named patient basis) allows a veterinarian to request a specific, unapproved medicine for a particular patient from the manufacturer, even if the drug is not yet authorized in that patient's country. 

New Animal Drug Application (NADA) 

A new animal drug is defined, in part, as any drug intended for use in animals other than man, including any drug intended for use in animal feed, but not including the animal feed, the composition of which is such that the drug is not generally recognized as safe and effective for the use under the conditions prescribed, recommended, or suggested in the labeling of the drug.

Personal Importation 

Personal importation refers to the practice of individuals bringing goods, often medicines or other health products, into a country for their own use, rather than for commercial sale or distribution.  

Prepositioning (Canada) 

"Pre-positioning" in the context of Health Canada refers to the early importation and placement of health products (such as COVID-19 drugs or public health emergency drugs) into Canadian facilities before they are officially authorized for sale. This mechanism is designed to ensure immediate distribution to Canadians upon authorization. 

Veterinary Real-World Data (RWD) 

Veterinary Real-World Data (RWD) refers to information regarding animal health status or the delivery of veterinary care collected routinely outside of traditional clinical trials. It captures everyday clinical findings, treatment effectiveness, and safety from varied sources, including electronic health records (EHRs), diagnostic labs, and wearable devices. 

Special Access Program (SAP, Canada) 

Health Canada's Special Access Program (SAP) allows healthcare professionals to request, on a case-by-case basis, access to unauthorized drugs or medical devices for patients with serious or life-threatening conditions. The program applies when conventional therapies have failed, are unavailable, or are unsuitable. 

USDA 

The United States Department of Agriculture is a federal executive department responsible for developing and executing policies related to farming, agriculture, forestry, food, and rural development. 

USDA Emergency Access (EUA) 

The USDA Veterinary Services (VS) provides leadership and coordination for emergency responses related to animal health incidents, including disease outbreaks and natural disasters.

Veterinary Compounding 

Veterinary compounding is the process of customizing medications for animals by combining, mixing, or altering ingredients to create a drug tailored to the individual needs of a specific animal or a small group of animals. 

Veterinary Innovation Program (PIP) 

Designed to help developers of animal biotechnology products (e.g., intentional genomic alterations) navigate the regulatory process. 

(Veterinary) Medical Devices 

The key difference between an animal drug and an animal device is how the product works. If it relies on a chemical action occurring in or on the animal’s body to achieve its primary intended effects, the product is a drug, not a device. If it needs to be broken down (metabolized) by the animal’s body to work, the product is a drug, not a device. 

Antibiotics, anesthetics, and insulin are examples of drugs. Needles, syringes, surgical instruments, X-ray equipment, certain diagnostic test kits, and dental appliances are examples of devices. 

Veterinary Marketing Exemption 

Veterinary drug marketing exemptions allow specific, unlicensed products—such as those for small pets (fish, rodents), investigational drugs, or certain compounded preparations—to be marketed or used without full regulatory approval. These exemptions often apply to non-prescription medicines, minor species pets, and research products, provided they meet safety labeling, advertising, and manufacturing standards 

‍ ‍