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  2. Thalidomide scandal - Wikipedia

    en.wikipedia.org/wiki/Thalidomide_scandal

    Feet of a baby born to a mother who had taken thalidomide while pregnant. In the late 1950s and early 1960s, the use of thalidomide in 46 countries was prescribed to women who were pregnant or who subsequently became pregnant, and consequently resulted in the "biggest anthropogenic medical disaster ever," with more than 10,000 children born with a range of severe deformities, such as ...

  3. Kefauver–Harris Amendment - Wikipedia

    en.wikipedia.org/wiki/Kefauver–Harris_Amendment

    The U.S. Kefauver–Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, [1] [2] required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed ...

  4. Thalidomide - Wikipedia

    en.wikipedia.org/wiki/Thalidomide

    Thalidomide, sold under the brand names Contergan and Thalomid among others, is an oral medication used to treat a number of cancers (e.g., multiple myeloma), graft-versus-host disease, and many skin disorders (e.g., complications of leprosy such as skin lesions).

  5. Frances Oldham Kelsey - Wikipedia

    en.wikipedia.org/wiki/Frances_Oldham_Kelsey

    Frances Kathleen Oldham Kelsey CM (née Oldham; July 24, 1914 – August 7, 2015) was a Canadian-American [1] pharmacologist and physician. As a reviewer for the U.S. Food and Drug Administration (FDA), she refused to authorize thalidomide for market because she had concerns about the lack of evidence regarding the drug's safety. [2]

  6. Orphan Drug Act of 1983 - Wikipedia

    en.wikipedia.org/wiki/Orphan_Drug_Act_of_1983

    In response to incidents such as difficulties with thalidomide the Kefauver-Harris Amendment was passed in 1962 as an amendment to the Federal Food, Drug, and Cosmetic Act. Kefauver-Harris required that all drugs approved for sale be proven safe and effective via rigorous scientific studies.

  7. Directive 65/65/EEC - Wikipedia

    en.wikipedia.org/wiki/Directive_65/65/EEC

    On the history of the Contergan (thalidomide) catastrophe in the light of drug legislation, Dtsch Med Wochenschr. 2001 October 19;126(42):1183-6. Shah RR., Thalidomide, drug safety and early drug regulation in the UK, Adverse Drug React Toxicol Rev. 2001 Dec;20(4):199-255.

  8. Marion Merrell Dow - Wikipedia

    en.wikipedia.org/wiki/Marion_Merrell_Dow

    Marion Merrell Dow and its predecessor Marion Laboratories was a U.S. pharmaceutical company based in Kansas City, Missouri, from 1950 until 1996.. The company specialized in bringing to market drugs that had been discovered but unmarketed by other companies including Cardizem which treats arrhythmias and high blood pressure, Carafate (an ulcer treatment), Gaviscon (an antacid), Seldane (a ...

  9. Drug of last resort - Wikipedia

    en.wikipedia.org/wiki/Drug_of_last_resort

    Thalidomide — withdrawn in 1961 owing to widespread incidence of severe birth defects (phocomelia or tetraamelia) after prenatal use by pregnant women, US Food and Drug Administration approved thalidomide for erythema nodosum leprosum (ENL) in 1998, and 2008 for new cases of multiple myeloma (administered with dexamethasone). A large "off ...