This draft guidance provides recommendations on how to interpret the pediatric study requirements of the Pediatric Research Equity Act (Public Law 108-155) (PREA).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).
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.