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National Drug Code Directory 76 recent views
The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared,... -
Drugs@FDA Database 41 recent views
Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of the drug... -
Drug Establishments Current Registration Site 18 recent views
The Drug Establishments Current Registration Site (DECRS) is a database of current information submitted by drug firms to register establishments (facilities) which manufacture,... -
FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files 12 recent views
The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database is designed... -
Inactive ingredient Search for Approved Drug Products 12 recent views
According to 21 CFR 210.3(b)(8), an inactive ingredient is any component of a drug product other than the active ingredient. Only inactive ingredients in the final dosage forms... -
Clinical Investigator Inspector List (CLIIL) 10 recent views
The Clinical Investigator Inspection List (CLIIL) contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have... -
Dissolution Methods Database
For a drug product that does not have a dissolution test method in the United States Pharmacopeia (USP), the FDA Dissolution Methods Database provides information on dissolution... -
Drugs to be Discontinued
Companies are required under Section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (as amended by the Food and Drug Administration Safety and Innovation Act)... -
Approved Drug Products with Therapuetic Equivalence Evaluations (Orange Book)
The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the basis of... -
Current and Resolved Drug Shortages and Discontinuations Reported to FDA
Information provided to FDA by manufacturers about current drugs in shortage, resolved shortages, and discontinuations of specific drug products. -
Bioresearch Monitonoring Information System (BMIS)
This contains information that identifies clinical investigators, contract research organizations, and institutional review boards involved in the conduct of Investigational New... -
Approved Risk Evaluation and Mitigation Strategies
The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the... -
Postmarket Requirements and Commitments
Provides information to the public on postmarket requirements and commitments. The phrase postmarket requirements and commitments refers to studies and clinical trials that...