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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
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
Premarket Approvals (PMA)
U.S. Department of Health & Human Services —
Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An... -
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
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
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
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... -
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
FDA Pet Food Recalls
U.S. Department of Health & Human Services —
Contains data for FDA pet food recalls since January 1, 2006. -
Federal
Recalls of Food and Dietary Supplements
U.S. Department of Health & Human Services —
Food producers recall their products from the marketplace when the products are mislabeled or when the food may present a health hazard to consumers because the food... -
Federal
CDRH Inspections Database
U.S. Department of Health & Human Services —
The CDRH Inspections Database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present. -
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
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 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
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
Post-Approval Studies
U.S. Department of Health & Human Services —
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a... -
Federal
Bioresearch Monitonoring Information System (BMIS)
U.S. Department of Health & Human Services —
This contains information that identifies clinical investigators, contract research organizations, and institutional review boards involved in the conduct of... -
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
Food Recalls
U.S. Department of Health & Human Services —
Press Releases of food recalls from industry -
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...