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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
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
FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files
U.S. Department of Health & Human Services —
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... -
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
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
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
Adverse Event Reporting System (AERS)
U.S. Department of Health & Human Services —
The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all... -
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
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
FDA Pet Food Recalls
U.S. Department of Health & Human Services —
Contains data for FDA pet food recalls since January 1, 2006. -
Federal
FDA Online Label Repository
U.S. Department of Health & Human Services —
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... -
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
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
FDA Acronyms and Abbreviations
U.S. Department of Health & Human Services —
The FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities -
Federal
FDA Pet Health and Safety Widget
U.S. Department of Health & Human Services —
Contains data for FDA pet food recalls since January 1, 2006. -
Federal
Clinical Laboratory Improvement Amendments
U.S. Department of Health & Human Services —
This database contains the commercially marketed in vitro test systems categorized by the FDA since January 31, 2000, and tests categorized by the Centers for Disease... -
Federal
Human Cell and Tissue Establishment Registration Public Query
U.S. Department of Health & Human Services —
This application provides Human Cell and Tissue registration information for registered, inactive, and pre-registered firms. Query options are by Establishment Name,... -
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
CFSAN Web Modules
U.S. Department of Health & Human Services —
This system shares public data that can be downloaded.