The Kefauver Amendment of 1962 requires the FDA to approve drugs based on proven effectiveness, not just safety.
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Q19: The Food, Drug and Cosmetic Act of
Q20: The Delaney Clause (the Food Additives Amendment)
Q21: The FDA decides what drugs may be
Q22: Medical devices are subject to FDA regulation.
Q23: In Wyeth v. Levine the Supreme Court
Q25: In Wyeth v. Levine the Supreme Court
Q26: Most advanced European nations have substantially stronger
Q27: It costs about $25 million and takes
Q28: Medical devices approved by the FDA before
Q29: It takes about $1 billion for a
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