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Drugs@FDA Database 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... -
National Drug Code Directory 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,... -
FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files 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... -
Drug Establishments Current Registration Site 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,... -
Clinical Investigator Inspector List (CLIIL) recent views
The Clinical Investigator Inspection List (CLIIL) contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have... -
Inactive ingredient Search for Approved Drug Products 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... -
FDA Acronyms and Abbreviations recent views
The FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities -
Adverse Event Reporting System (AERS) recent views
The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug... -
Product Classification recent views
This database contains medical device names and associated information developed by the Center. It includes a three letter device product code and a Device Class that refers to... -
FDA Online Label Repository recent views
The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug... -
Premarket Notifications (510(k)s) recent views
Medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce a device into commercial distribution for the first time or... -
Postmarket Requirements and Commitments recent views
Provides information to the public on postmarket requirements and commitments. The phrase postmarket requirements and commitments refers to studies and clinical trials that... -
Electronic Animal Drug Product Listing Directory recent views
The Electronic Animal Drug Product Listing Directory is a directory of all animal drug products that have been listed electronically since June 1, 2009, to comply with changes... -
MedWatch Safety Alerts for Human Medical Products recent views
MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts contain... -
X-Ray Assembler Data recent views
Federal regulations require that an assembler who installs one or more certified components of a diagnostic x-ray system submit a report of assembly. This database contains the... -
Bioresearch Monitonoring Information System (BMIS) recent views
This contains information that identifies clinical investigators, contract research organizations, and institutional review boards involved in the conduct of Investigational New... -
Approved Drug Products with Therapuetic Equivalence Evaluations (Orange Book) recent views
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...
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