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  2. Food and Drug Administration Amendments Act of 2007

    en.wikipedia.org/wiki/Food_and_Drug...

    It prohibits interstate commerce of any food that has an approved drug, licensed biological product, or certain other drugs or biological products added, unless the drug or biological product was marketed in food prior to approval, licensure, or clinical investigation, the FDA has approved the use of such drug or biological product in the food ...

  3. Approved Drug Products with Therapeutic Equivalence ...

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

    inducing pioneering research and development of new drugs and; enabling competitors to bring low-cost, generic copies of those drugs to market'". [1] The Orange Book identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act.

  4. List of drugs granted breakthrough therapy designation

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

    To be used in conjunction with food allergen avoidance [2] Osimertinib: In combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test [2 ...

  5. Food and Drug Administration Safety and Innovation Act

    en.wikipedia.org/wiki/Food_and_Drug...

    The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.

  6. List of androgens/anabolic steroids available in the United ...

    en.wikipedia.org/wiki/List_of_androgens/anabolic...

    This is a complete list of androgens/anabolic steroids (AAS) and formulations that are approved by the FDA Tooltip Food and Drug Administration and available in the United States. AAS like testosterone are used in androgen replacement therapy (ART), a form of hormone replacement therapy (HRT), and for other indications.

  7. Food and Drug Administration - Wikipedia

    en.wikipedia.org/wiki/Food_and_Drug_Administration

    The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...

  8. Approved drug - Wikipedia

    en.wikipedia.org/wiki/Approved_drug

    The center doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards. As of the end of 2013, the FDA and its predecessors had approved 1,452 drugs, though not all are still available, and some have been withdrawn for safety reasons. [5]

  9. Category:Food and Drug Administration - Wikipedia

    en.wikipedia.org/wiki/Category:Food_and_Drug...

    FDA Consumer; FDA Food Safety Modernization Act; FDA Most Wanted Fugitives; FDA preemption; FDA recall policies; FDA v. Alliance for Hippocratic Medicine; FDA v. Brown & Williamson Tobacco Corp. FDA warning letter; Federal Food, Drug, and Cosmetic Act of 1938; First-in-class medication; Food Additives Amendment of 1958; Food and Drug ...