FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act Guidance for Industry May 2021

GUIDANCE DOCUMENT

• Docket Number: FDA-2019-D-4751
• Issued by: Oncology Center of Excellence; Center for Drug Evaluation and Research

This guidance addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs for which original New Drug Applications (NDAs) and Biologics License Applications (BLAs) are expected to be submitted to the FDA, in accordance with section 505B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (also referred to as the Pediatric Research Equity Act, or PREA) as amended by the FDA Reauthorization Act of 2017 (FDARA).  Early pediatric evaluation of certain molecularly targeted oncology drugs as required by section 505B(a)(1)(B) of the FD&C Act is expected to accelerate the creation of a pediatric development plan and ultimately the development of promising drugs for pediatric patients.

This guidance addresses the implementation of amendments made by FDARA section 504 to section 505B of the FD&C Act regarding molecularly targeted oncology drugs. This guidance does not address in detail the general requirements for development of drugs for pediatric use under PREA or section 505A of the FD&C Act (also referred to as the Best Pharmaceuticals for Children Act, or BPCA).

---

Submit Comments

Submit Comments Online

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:

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-4751.

Questions?