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86 datasets found
  • Federal

    National Drug Code Directory 108 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

    FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files 50 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

    Drugs@FDA Database 33 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

    Drug Establishments Current Registration Site 25 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

    Orange Book 20 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

    CLIA Currently Waived Analytes 19 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

    FDA Recognized Consensus Standards 14 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

    Inactive ingredient Search for Approved Drug Products 12 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

    NHRIC (National Health Related Items Code) 12 recent views

    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

    Total Product Life Cycle (TPLC) 10 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

    Approved Animal Drug Products (Green Book) 10 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

    MDR (Medical Device Reporting) 10 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

    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

    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

    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 Medical Devices

    U.S. Department of Health & Human Services —

    This database contains a list of classified medical device recalls since November 1, 2002
  • Federal

    GUDID Download

    U.S. Department of Health & Human Services —

    The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique...
  • 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

    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

    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...
86 datasets found

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