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  • 86 datasets found

    Publishers: U.S. Food and Drug Administration

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    • National Drug Code Directory 116 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,...

    • FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files 37 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...

    • Drugs@FDA Database 33 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...

    • NHRIC (National Health Related Items Code) 32 recent views

      The National Health Related Items Code (NHRIC) is a system for identification and numbering of marketed device packages that is compatible with other numbering systems such as...

    • Drug Establishments Current Registration Site 20 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,...

    • Total Product Life Cycle (TPLC) 19 recent views

      The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases including...

    • Inactive ingredient Search for Approved Drug Products 16 recent views

      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...

    • MDR (Medical Device Reporting) 14 recent views

      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 years 1992...

    • Product Classification 14 recent views

      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...

    • CLIA Currently Waived Analytes 14 recent views

      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 Control and...

    • FDA Drug Label Data 10 recent views

      This file contains the data elements used for searching the FDA Online Data Repository including proprietary name, active ingredients, marketing application number or regulatory...

    • FDA Recognized Consensus Standards 10 recent views

      This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information the Center...

    • FDA Pet Food Recalls

      Contains data for FDA pet food recalls since January 1, 2006.

    • Orange Book

      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 and provides...

    • FDA Data Inventory

      An inventory of all FDA Datasets

    • 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

    • Inspection Database

      FDA is disclosing the final inspection classification for inspections related to currently marketed FDA-regulated products. The disclosure of this information is not intended to...

    • 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...

    • Adverse Event Reporting System (AERS)

      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...

    • 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...