Buy custom The Price We Pay: The Efficacy Requirement For New Drugs
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Business
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| Number of pages / Number of words: |
16 / 4309 |
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. ." 21 U.S.C. § 321(p) (1988). to act within sixty days. In 1962, however, Congress passed the Drug Amendments in response to another tragedy, the thalidomide tragedy that occurred in European countries. The Drug Amendments did away with the system of automatic approval, but are better known for adding the efficacy requirement to the NDA process...
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§ 321(p) (1988). to act within sixty days. In 1962, however, Congress passed the Drug Amendments in response to another tragedy, the thalidomide tragedy that occurred in European countries. The Drug Amendments did away with the system of automatic approval, but are better known for adding the efficacy requirement to the NDA process...
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