pediatric studies
Defined in 1 place of the United States Code.
As used in this section, the term “pediatric studies” or “studies” means at least one clinical investigation (that, at the Secretary's discretion, may include pharmacokinetic studies) in pediatric age groups in which a drug is anticipated to be used.
Source
- 1997–200121 U.S.C. § 355AFood and Drugs · Pediatric studies of drugs · as used in this section
As used in this section, the term “pediatric studies” or “studies” means at least one clinical investigation (that, at the Secretary's discretion, may include pharmacokinetic studies) in pediatric age groups (including neonates in appropriate cases) in which a drug is anticipated to be used.
Source
- 2001–200721 U.S.C. § 355AFood and Drugs · Pediatric studies of drugs · as used in this section
As used in this section, the term “pediatric studies” or “studies” means at least one clinical investigation (that, at the Secretary's discretion, may include pharmacokinetic studies) in pediatric age groups (including neonates in appropriate cases) in which a drug is anticipated to be used, and, at the discretion of the Secretary, may include preclinical studies.
Source
- 2007–present21 U.S.C. § 355AFood and Drugs · Pediatric studies of drugs · as used in this section