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13 datasets found
  • Federal

    National Drug Code Directory 100 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 48 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 39 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 32 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

    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

    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

    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

    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 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

    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

    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

    Approved Risk Evaluation and Mitigation Strategies

    U.S. Department of Health & Human Services —

    The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to...
  • 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...
13 datasets found

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