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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
Orange Book
U.S. Department of Health & Human Services —
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... -
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
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
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
Warning Letters
U.S. Department of Health & Human Services —
An index of FDA warning letters issued to companies operating in the United States. -
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
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
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
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
FDA Drug Label Data
U.S. Department of Health & Human Services —
This file contains the data elements used for searching the FDA Online Data Repository including proprietary name, active ingredients, marketing application number or... -
Federal
Food Recalls
U.S. Department of Health & Human Services —
Press Releases of food recalls from industry -
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
X-Ray Assembler Data
U.S. Department of Health & Human Services —
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... -
Federal
MedSun Reports
U.S. Department of Health & Human Services —
The Medical Product Safety Network (MedSun) is an adverse event reporting program launched in 2002. The primary goal for MedSun is to work collaboratively with the... -
Federal
Food Code Reference System
U.S. Department of Health & Human Services —
The Food Code Reference System (FCRS) is a searchable database that provides access to FDA�s interpretative positions and responses to questions related to the FDA...