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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
National Drug Code Directory
U.S. Department of Health & Human Services —
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,... -
Federal
Premarket Notifications (510(k)s)
U.S. Department of Health & Human Services —
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... -
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
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
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
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
Inactive ingredient Search for Approved Drug Products
U.S. Department of Health & Human Services —
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... -
Federal
Total Product Life Cycle (TPLC)
U.S. Department of Health & Human Services —
The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases... -
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
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
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
Warning Letters
U.S. Department of Health & Human Services —
An index of FDA warning letters issued to companies operating in the United States. -
Federal
Approved Drug Products with Therapuetic Equivalence Evaluations (Orange Book)
U.S. Department of Health & Human Services —
The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the... -
Federal
Mammography Facilities
U.S. Department of Health & Human Services —
The Mammography Facility Database is updated periodically based on information received from the four FDA-approved accreditation bodies: the American College of... -
Federal
Blood Establishment Registration Database
U.S. Department of Health & Human Services —
This application provides information for active, inactive, and pre-registered firms. Query options are by FEI, Applicant Name, Establishment Name, Other Names,... -
Federal
Inspection Citations
U.S. Department of Health & Human Services —
Disclosure of reporting citations provide the public with a rationale for the Agency�s enforcement actions and will also help to inform public and industry decision-... -
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...