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  • 17 datasets found

    Harvest Source: Healthdata.gov Publishers: U.S. Food and Drug Administration Formats: ZIP

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    • National Drug Code Directory 101 recent views

      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, prepared,...

    • Drugs@FDA Database 50 recent views

      Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of the drug...

    • Clinical Investigator Inspector List (CLIIL) 15 recent views

      The Clinical Investigator Inspection List (CLIIL) contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have...

    • FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files 13 recent views

      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 designed...

    • Drug Establishments Current Registration Site 11 recent views

      The Drug Establishments Current Registration Site (DECRS) is a database of current information submitted by drug firms to register establishments (facilities) which manufacture,...

    • Adverse Event Reporting System (AERS) 11 recent views

      The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug...

    • Inactive ingredient Search for Approved Drug Products

      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 dosage forms...

    • MedWatch Safety Alerts for Human Medical Products

      MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts contain...

    • Premarket Notifications (510(k)s)

      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 time or...

    • Product Classification

      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 refers to...

    • FDA Acronyms and Abbreviations

      The FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities

    • Approved Drug Products with Therapuetic Equivalence Evaluations (Orange Book)

      The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the basis of...

    • Bioresearch Monitonoring Information System (BMIS)

      This contains information that identifies clinical investigators, contract research organizations, and institutional review boards involved in the conduct of Investigational New...

    • X-Ray Assembler Data

      Federal regulations require that an assembler who installs one or more certified components of a diagnostic x-ray system submit a report of assembly. This database contains the...

    • Electronic Animal Drug Product Listing Directory

      The Electronic Animal Drug Product Listing Directory is a directory of all animal drug products that have been listed electronically since June 1, 2009, to comply with changes...

    • FDA Online Label Repository

      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...

    • Postmarket Requirements and Commitments

      Provides information to the public on postmarket requirements and commitments. The phrase postmarket requirements and commitments refers to studies and clinical trials that...