adequate and well-controlled studies
Glossaries
| Term | Definition |
|---|---|
| adequate and well-controlled studies |
Studies used to support drug marketing authorization and intended to provide substantial evidence of effectiveness required by law to support a conclusion that a drug is effective. NOTE: For additional information see COA glossary of terms. [After 1. FDA Clinical Outcome Assessment (COA) Glossary; 2. 21 CFR 314.126]
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