Biomaterial Database

Regulatory process for drugs used by the poultry industry. 1994

M K Terry

Animal Health Institute, Alexandria, Virginia 22314-1917.

The availability of safe and effective drugs to treat and control poultry diseases and to enhance the efficiency of poultry production depends on the rate at which new drugs are approved by the Food and Drug Administration. This paper briefly describes the components of the regulatory approval process for a new animal drug for use in food-producing animals, with specific reference to some problems encountered in the approval process for poultry drugs.

UI	MeSH Term	Description	Entries
D007880	Legislation, Drug	Laws concerned with manufacturing, dispensing, and marketing of drugs.	Drug Laws,Food, Drug and Cosmetic Act,Narcotic Laws,Drug Legislation,Drug Law,Law, Drug,Law, Narcotic,Laws, Drug,Laws, Narcotic,Narcotic Law
D011200	Poultry	Domesticated birds raised for food. It typically includes CHICKENS; TURKEYS, DUCKS; GEESE; and others.	Fowls, Domestic,Domestic Fowl,Domestic Fowls,Fowl, Domestic,Poultries
D004341	Drug Evaluation	Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals.	Evaluation Studies, Drug,Drug Evaluation Studies,Drug Evaluation Study,Drug Evaluations,Evaluation Study, Drug,Evaluation, Drug,Evaluations, Drug,Studies, Drug Evaluation,Study, Drug Evaluation
D000818	Animals	Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA.	Animal,Metazoa,Animalia
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.
D014486	United States Food and Drug Administration	An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.	Food and Drug Administration (U.S.),USFDA,Food and Drug Administration,United States Food, Drug Administration
D017277	Drug Approval	Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.	Drug Approval Process,New Drug Approval,Food and Drug Administration Drug Approval,Food and Drug Administration Drug Approval Process,New Drug Approval Process,Approval Process, Drug,Approval Processes, Drug,Approval, Drug,Approval, New Drug,Approvals, Drug,Approvals, New Drug,Drug Approval Processes,Drug Approval, New,Drug Approvals,Drug Approvals, New,New Drug Approvals,Process, Drug Approval,Processes, Drug Approval