effectiveness
Glossaries
Term | Definition |
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effectiveness |
A measure of intended effect on the disease or condition based on regulatory determination made on the basis of clinical efficacy and other substantial evidence, including real-world observations. [After Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. FDA GUIDANCE DOCUMENT. MAY 1998. After Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. FDA Guidance for Industry (DRAFT GUIDANCE). December 2019] See also efficacy.
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