qualified indication
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 355 — in this section
the term “qualified indication” means an indication for a drug that the Secretary determines to be appropriate for summary level review under this paragraph; and
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.