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GUIDANCE DOCUMENT

Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 Questions and Answers Draft Guidance for Industry January 2020

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
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


Docket Number:
FDA-2019-D-4752
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Oncology Center of Excellence
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research
Office of Medical Products and Tobacco, Center 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).

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