- Docket Number:
- Issued by:
Guidance Issuing OfficeOncology Center of ExcellenceCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
The purpose of this guidance is to provide information to sponsors regarding the submission of an initial pediatric study plan (iPSP), as required by section 505B(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), for oncology drugs only. Specifically, this guidance provides FDA’s current thinking regarding iPSPs for oncology drugs in light of the amendments to section 505B of the FD&C Act (also referred to as the Pediatric Research Equity Act, or PREA) made by section 504 of the FDA Reauthorization Act of 2017 (FDARA). FDA has received a number of questions on this topic and, as a result, is providing guidance in a question and answer format, addressing the most frequently asked questions.
This guidance does not contain a complete discussion of general requirements for development 28 of drugs for pediatric use under PREA or section 505A of the FD&C Act (also referred to as the 29 Best Pharmaceuticals for Children Act or BPCA).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2019-D-4752.