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National Drug Code Directory 99 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 43 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 17 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,... -
Total Product Life Cycle (TPLC) 17 recent views
The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases including... -
Orange Book 13 recent views
The Approved Drug Products with Therapeutic Equivalence (Orange Book or OB) is a list of drugs approved under Section 505 of the Federal Food, Drug and Cosmetic Act and provides... -
NHRIC (National Health Related Items Code) 13 recent views
The National Health Related Items Code (NHRIC) is a system for identification and numbering of marketed device packages that is compatible with other numbering systems such as... -
Adverse Event Reporting System (AERS) 12 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... -
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 11 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... -
CLIA Currently Waived Analytes 10 recent views
This database contains the commercially marketed in vitro test systems categorized as CLIA waived by the FDA since January 31, 2000, and by the Centers for Disease Control and... -
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... -
MDR (Medical Device Reporting)
This database allows you to search the CDRH's database information on medical devices which may have malfunctioned or caused a death or serious injury during the years 1992... -
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... -
FDA Recognized Consensus Standards
This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information the Center... -
POCA -Phonetic Orthographic Computer Algorithm
POCA is a software that produces a data set used internally to assess the safety, and feasibility of proposed proprietary drug names. FDA product name safety evaluators have... -
Approved Animal Drug Products (Green Book)
On November 16, 1988, the President of the United States signed into law the Generic Animal Drug and Patent Restoration Act (GADPTRA). Among its major provisions, the Act... -
CDRH FOIA Electronic Reading Room
The CDRH FOIA electronic reading room contains frequently requested information via the Freedom of Information Act from the Center for Devices and Radiological Health. -
MedWatch Safety Alerts for Human Medical Products
MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts contain... -
Premarket Notifications (510(k)s)
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... -
FDA Drug Label Data
This file contains the data elements used for searching the FDA Online Data Repository including proprietary name, active ingredients, marketing application number or regulatory...
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