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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
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
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
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
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
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
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
FDA Pet Food Recalls
U.S. Department of Health & Human Services —
Contains data for FDA pet food recalls since January 1, 2006. -
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
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
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
Drugs to be Discontinued
U.S. Department of Health & Human Services —
Companies are required under Section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (as amended by the Food and Drug Administration Safety and... -
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... -
Federal
MedWatch Safety Alerts for Human Medical Products
U.S. Department of Health & Human Services —
MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts... -
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
Postmarket Requirements and Commitments
U.S. Department of Health & Human Services —
Provides information to the public on postmarket requirements and commitments. The phrase postmarket requirements and commitments refers to studies and clinical... -
Federal
FDA Pistachio Product Recalls Widget
U.S. Department of Health & Human Services —
Contains data for FDA pistachio product recalls since March 2009.