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The Clinical Investigator Inspection List (CLIIL) contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have performed studies with investigational new drugs.…
Updated Oct 29, 2026
HealthData.Gov
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 methods presently recommended by the…
Updated Oct 29, 2026
HealthData.Gov
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 products approved since 1939. The majority of…
Updated Oct 29, 2026
HealthData.Gov
The Drug Establishments Current Registration Site (DECRS) is a database of current information submitted by drug firms to register establishments (facilities) which manufacture, prepare, propagate, compound or process…
Updated Oct 29, 2026
HealthData.Gov
Information provided to FDA by manufacturers about current drugs in shortage, resolved shortages, and discontinuations of specific drug products.
Updated Oct 29, 2026
HealthData.Gov
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, propagated, compounded, or processed by it…
Updated Oct 29, 2026
HealthData.Gov
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 safety and effectiveness by the Food and…
Updated Oct 29, 2026
HealthData.Gov
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 to support the FDA's post-marketing safety…
Updated Oct 29, 2026
HealthData.Gov
Provides information to the public on postmarket requirements and commitments. The phrase postmarket requirements and commitments refers to studies and clinical trials that sponsors conduct after approval to gather…
Updated Oct 29, 2026
