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Federal
Drugs@FDA Database
U.S. Department of Health & Human Services —
Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of... -
Federal
MAUDE (Manufacturer and User Facility Device Experience)
U.S. Department of Health & Human Services —
MAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since... -
Federal
Warning Letters
U.S. Department of Health & Human Services —
An index of FDA warning letters issued to companies operating in the United States. -
Federal
CLIA Currently Waived Analytes
U.S. Department of Health & Human Services —
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... -
Federal
Drug Establishments Current Registration Site
U.S. Department of Health & Human Services —
The Drug Establishments Current Registration Site (DECRS) is a database of current information submitted by drug firms to register establishments (facilities) which... -
Federal
FDA Recognized Consensus Standards
U.S. Department of Health & Human Services —
This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information... -
Federal
Current and Resolved Drug Shortages and Discontinuations Reported to FDA
U.S. Department of Health & Human Services —
Information provided to FDA by manufacturers about current drugs in shortage, resolved shortages, and discontinuations of specific drug products. -
Federal
Establishment Registration & Device Listing
U.S. Department of Health & Human Services —
This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices... -
Federal
Clinical Investigator Inspector List (CLIIL)
U.S. Department of Health & Human Services —
The Clinical Investigator Inspection List (CLIIL) contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who... -
Federal
Dissolution Methods Database
U.S. Department of Health & Human Services —
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... -
Federal
Product Classification
U.S. Department of Health & Human Services —
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... -
Federal
Approved Animal Drug Products (Green Book)
U.S. Department of Health & Human Services —
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... -
Federal
Enforcement Reports
U.S. Department of Health & Human Services —
Whereas not all recalls are announced in the media or on our Recalls press release page, all recalls montiored by FDA are included in FDA's weekly Enforcement Report... -
Federal
Inspection Database
U.S. Department of Health & Human Services —
FDA is disclosing the final inspection classification for inspections related to currently marketed FDA-regulated products. The disclosure of this information is not... -
Federal
Food Recalls
U.S. Department of Health & Human Services —
Press Releases of food recalls from industry -
Federal
NHRIC (National Health Related Items Code)
U.S. Department of Health & Human Services —
The National Health Related Items Code (NHRIC) is a system for identification and numbering of marketed device packages that is compatible with other numbering... -
Federal
POCA -Phonetic Orthographic Computer Algorithm
U.S. Department of Health & Human Services —
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... -
Federal
Electronic Animal Drug Product Listing Directory
U.S. Department of Health & Human Services —
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... -
Federal
Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes
U.S. Department of Health & Human Services —
A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved... -
Federal
MDR (Medical Device Reporting)
U.S. Department of Health & Human Services —
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...