qualified indication
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 indication” means an indication for a drug that the Secretary determines to be appropriate for summary level review under this paragraph; and
Source
- 2016–present21 U.S.C. § 355Food and Drugs · New drugs · in this section