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Single-Study Approvals: Quantum of Evidence Required

Pages: 216847901987391 - 216847901987391
Published: Sep 26, 2019
Abstract
When does a single positive adequate and well-controlled study of a new drug meet the statutory requirement to demonstrate substantial evidence of effectiveness? The answer to this question, particularly with respect to new molecular entities, has been of considerable debate since 1962 when the requirement that new drugs prove their benefit to patients became law. A 1997 revision to the statute provided one pathway to a single-study approval (a...
Paper Details
Title
Single-Study Approvals: Quantum of Evidence Required
Published Date
Sep 26, 2019
Pages
216847901987391 - 216847901987391
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