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  2. List of drugs granted breakthrough therapy designation

    en.wikipedia.org/wiki/List_of_drugs_granted...

    Amgen. non-small cell lung cancer with KRAS G12C mutation. Avapritinib. Blueprint Medicines Corp. granted for two indications: mast cell leukemia and advanced systemic mastocytosis. Belumosudil. Kadmon Pharmaceuticals. chronic graft-versus-host disease. Pembrolizumab.

  3. List of academic databases and search engines - Wikipedia

    en.wikipedia.org/wiki/List_of_academic_databases...

    Biomedical database with a focus on drug and pharmaceutical research. Rrecords from over 8,500 journals (1947–present). Subscription Elsevier: FSTA – Food Science and Technology Abstracts: Food science, Food technology, Nutrition: 1,500,000 The database of information on food science, food technology and nutrition Subscription

  4. National drug code - Wikipedia

    en.wikipedia.org/wiki/National_Drug_Code

    The national drug code (NDC) is a unique product identifier used in the United States for drugs intended for human use. The Drug Listing Act of 1972 [ 1 ] [ 2 ] requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed ...

  5. JANUS clinical trial data repository - Wikipedia

    en.wikipedia.org/wiki/JANUS_clinical_trial_data...

    JANUS clinical trial data repository. Janus clinical trial data repository is a clinical trial data repository (or data warehouse) standard as sanctioned by the U.S. Food and Drug Administration (FDA). It was named for the Roman god Janus (mythology), who had two faces, one that could see in the past and one that could see in the future.

  6. First Databank - Wikipedia

    en.wikipedia.org/wiki/First_Databank

    Website. fdbhealth .com. First Databank ( FDB) is a major provider of drug and medical device databases that help inform healthcare professionals to make decisions. [1] FDB partners with information system developers to deliver useful medication- and medical device-related information to clinicians, business associates, and patients.

  7. Approved drug - Wikipedia

    en.wikipedia.org/wiki/Approved_drug

    Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition. Drug companies seeking to sell a drug in the United States must first test it.

  8. Approved Drug Products with Therapeutic Equivalence ...

    en.wikipedia.org/wiki/Approved_Drug_Products...

    Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests ...

  9. Pharmaceutical code - Wikipedia

    en.wikipedia.org/wiki/Pharmaceutical_code

    Pharmaceutical code. Pharmaceutical codes are used in medical classification to uniquely identify medication. They may uniquely identify an active ingredient, drug system (including inactive ingredients and time-release agents) in general, or a specific pharmaceutical product from a specific manufacturer.