> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Pharmacology Pediatric Studies Guidance
- URL: https://www.fdaweb.com/pharmacology-pediatric-studies-guidance/
- Published: 2022-09-07T12:00:00.000Z
- Updated: 2026-09-14T17:58:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152679

FDA has published a draft guidance, *General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products*, to assist sponsors of INDs, Section 505 NDAs, BLAs, and supplements to those applications who are planning to conduct clinical studies in pediatric populations. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-clinical-pharmacology-considerations-pediatric-studies-drugs-including-biological-products?ref=fdaweb.com) also is intended to assist clinical investigators in the design and planning of, and Institutional Review Boards in the assessment of, clinical studies in pediatric populations.

“The guidance addresses general clinical pharmacology considerations for conducting studies so that the dosing and safety information for drugs in pediatric populations can be sufficiently characterized, leading to well-designed trials to evaluate effectiveness,” the guidance says.

It does not describe **(1)** the standards for the approval of drugs in the pediatric population; **(2)** the determination that the course of a disease is the same in adults and pediatric populations; or **(3)** the clinical pharmacology studies for the development of vaccine therapies, blood products, or other products not regulated by CDER.