Issue Date: September 7, 2005
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural, Pediatric Product Development
Status: Draft
How to Comply with the Pediatric Research Equity Act
This draft guidance provides recommendations on how to interpret the pediatric study requirements of the Pediatric Research Equity Act (Public Law 108-155) (PREA). PREA amends the Federal Food, Drug, and Cosmetic Act (the Act) by adding section 505B (21 U.S.C. 355B). PREA requires the conduct of pediatric studies for certain drug and biological products. 2 Specifically, PREA requires new drug applications (NDAs) and biologics licensing applications (BLAs) (or supplements to applications) for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration to contain a pediatric assessment unless the applicant has obtained a waiver or deferral (see section 505B(a) of the Act). It also authorizes FDA to require holders of applications for previously approved marketed drugs and biological products who are not seeking approval for one of the changes enumerated above (hereinafter “marketed drugs and biological products”) to submit a pediatric assessment under certain circumstances (see section 505B(b) of the Act).
Download the Guidance Document
