### Question
How is the term pediatric studies” or “studies defined?


### Answer
The term **pediatric studies” or “studies** is defined in *21 U.S.C. § 355a* as the following:

> 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

#### Citation:
  - *21 U.S.C. § 355a*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part A-Drugs and Devices**

