qualified data summary
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 355 — 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.
42 U.S.C. § 262 — in this section
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.