86 datasets found
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Federal
National Drug Code Directory recent views
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
Drugs@FDA Database recent views
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
FDA Recognized Consensus Standards recent views
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
Total Product Life Cycle (TPLC) recent views
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
Drug Establishments Current Registration Site recent views
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
CLIA Currently Waived Analytes recent views
U.S. Department of Health & Human Services —
This database contains the commercially marketed in vitro test systems categorized as CLIA waived by the FDA since January 31, 2000, and by the Centers for Disease... -
Federal
Inactive ingredient Search for Approved Drug Products recent views
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
Orange Book recent views
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
FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files recent views
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
Product Classification recent views
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
Approved Animal Drug Products (Green Book) recent views
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
Recalls of Medical Devices recent views
U.S. Department of Health & Human Services —
This database contains a list of classified medical device recalls since November 1, 2002 -
Federal
Adverse Event Reporting System (AERS) recent views
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
MDR (Medical Device Reporting) recent views
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
FDA Abbott Infant Formula Recall recent views
U.S. Department of Health & Human Services —
On September 22, 2010, Abbott issued a voluntary recall of certain Similac powdered infant formula after identifying a common warehouse beetle (both larvae and... -
Federal
Premarket Notifications (510(k)s) recent views
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
FDA Drug Label Data recent views
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
FDA Pet Food Recalls recent views
U.S. Department of Health & Human Services —
Contains data for FDA pet food recalls since January 1, 2006. -
Federal
Mammography Facilities recent views
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
Inspection Database recent views
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...
86 datasets found