-
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. -
Clinical Investigator Inspector List (CLIIL)
The Clinical Investigator Inspection List (CLIIL) contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have... -
FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files
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... -
Drugs@FDA Database
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... -
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... -
Drug Establishments Current Registration Site
The Drug Establishments Current Registration Site (DECRS) is a database of current information submitted by drug firms to register establishments (facilities) which manufacture,... -
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... -
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)...