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The national drug code (NDC) is a unique product identifier used in the United States for drugs intended for human use. The Drug Listing Act of 1972 [ 1 ] [ 2 ] requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed ...
Alpidem (Ananxyl) 1995. Worldwide. Not approved in the US, withdrawn in France in 1994 [4] and the rest of the market in 1995 because of rare but serious hepatotoxicity. [3] [5] Alosetron (Lotronex) 2000. US. Serious gastrointestinal adverse events; ischemic colitis; severe constipation. [2]
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
Physicians' Desk Reference. The Physicians' Desk Reference ( PDR ), renamed Prescriber's Digital Reference after its physical publication was discontinued, is a compilation of manufacturers' prescribing information ( package insert) on prescription drugs, updated regularly and published by ConnectiveRx. [citation needed]
The Agency carries out a number of activities, including: Pharmacovigilance: The Agency constantly monitors the safety of medicines through a pharmacovigilance network and EudraVigilance, so that it can take appropriate actions if adverse drug reaction reports suggest that the benefit-risk balance of a medicine has changed since it was authorised.
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests ...
The FDA Adverse Event Reporting System ( FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration 's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses FAERS to monitor for new adverse events and medication errors that might ...
Pharmaceutical code. Pharmaceutical codes are used in medical classification to uniquely identify medication. They may uniquely identify an active ingredient, drug system (including inactive ingredients and time-release agents) in general, or a specific pharmaceutical product from a specific manufacturer.