Biomaterial Database

The OTC drug approval process. The ACG Committee on FDA-Related Matters. American College of Gastroenterology. 1990

S B Fredd

The OTC drug monograph process and the NDA route of OTC drug approval are two different methods that reach the same result, the approval of safe and effective drugs. Both routes to OTC marketing require substantial evidence that the drugs are safe and effective for OTC use, including evidence that the drug would be safe for self-use without the supervision of a practitioner.

UI	MeSH Term	Description	Entries
D003257	Consumer Product Safety	The sum total of measures taken and regulatory policies enacted to ensure the safe use of consumer products.	Safety, Consumer Product,Product Approval,Product Approvals,Product Safety, Consumer
D004366	Nonprescription Drugs	Medicines that can be sold legally without a DRUG PRESCRIPTION.	Drugs, Non-Prescription,Non-Prescription Drug,Nonprescription Drug,OTC Drug,OTC Drugs,Over-the-Counter Drug,Over-the-Counter Drugs,Patent Medicine,Patent Medicines,Drugs, Nonprescription,Medicines, Patent,Non-Prescription Drugs,Drug, Non-Prescription,Drug, Nonprescription,Drug, OTC,Drug, Over-the-Counter,Drugs, Non Prescription,Drugs, OTC,Drugs, Over-the-Counter,Medicine, Patent,Non Prescription Drug,Non Prescription Drugs,Over the Counter Drug,Over the Counter Drugs
D000863	Antacids	Substances that counteract or neutralize acidity of the GASTROINTESTINAL TRACT.	Alkalinizing Agent,Antacid,Alkalinizing Agents,Agent, Alkalinizing,Agents, Alkalinizing
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
D015507	Drugs, Investigational	Drugs which have received FDA approval for human testing but have yet to be approved for commercial marketing. This includes drugs used for treatment while they still are undergoing clinical trials (Treatment IND). The main heading includes drugs under investigation in foreign countries.	Investigational Drug,Investigational New Drug,Investigational New Drugs,Investigational Drugs,Drug, Investigational,Drug, Investigational New,Drugs, Investigational New,New Drug, Investigational,New Drugs, Investigational