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Review
A review is the basis of FDA's decision to approve an application. It is a comprehensive analysis of clinical trial data and other information prepared by FDA drug application reviewers. A review is divided into sections on medical analysis, chemistry, clinical pharmacology, biopharmaceutics, pharmacology, statistics, and microbiology.
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- Part of Speech: noun
- Synonym(s):
- Blossary:
- Industry/Domain: Pharmaceutical
- Category: Drugs
- Company: U.S. FDA
- Product:
- Acronym-Abbreviation:
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