qualified data summary
Defined in 2 places across 2 titles of the United States Code.
In this subparagraph, the terms “qualified indication” and “qualified data summary” have the meanings given such terms in section 505(c)(5) of the Federal Food, Drug, and Cosmetic Act.
Source
- 2016–present42 U.S.C. § 262The Public Health and Welfare · Regulation of biological products · in this section
the term “qualified data summary” means a summary of clinical data that demonstrates the safety and effectiveness of a drug with respect to a qualified indication.
Source
- 2016–present21 U.S.C. § 355Food and Drugs · New drugs · in this section