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    FederalDrugs@FDA DatabaseU.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...
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    FederalMAUDE (Manufacturer and User Facility Device Experience)U.S. Department of Health & Human Services — MAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since...
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    FederalNational Drug Code DirectoryU.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,...
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    FederalOrange BookU.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...
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    FederalCLIA Currently Waived AnalytesU.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...
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    FederalPremarket Notifications (510(k)s)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...
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    FederalFDA Adverse Event Reporting System (FAERS): Latest Quartely Data FilesU.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...
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    FederalClinical 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...
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    FederalDrug Establishments Current Registration SiteU.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...
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    FederalWarning LettersU.S. Department of Health & Human Services — An index of FDA warning letters issued to companies operating in the United States.
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    FederalFDA Recognized Consensus StandardsU.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...
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    FederalInactive ingredient Search for Approved Drug ProductsU.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...
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    FederalEstablishment Registration & Device ListingU.S. Department of Health & Human Services — This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices...
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    FederalCurrent and Resolved Drug Shortages and Discontinuations Reported to FDAU.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.
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    FederalAdverse 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...
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    FederalTotal Product Life Cycle (TPLC)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...
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    FederalApproved Animal Drug Products (Green Book)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...
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    FederalAll FDA RecallsU.S. Department of Health & Human Services — Contains data for FDA recalls from 2009 through the present.
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    FederalDissolution Methods DatabaseU.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...
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    FederalProduct ClassificationU.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...
