Issue Date: May 24, 2021
Issued by: Oncology Center of Excellence
Topic(s): Clinical Trials, Administrative / Procedural, Pediatric Product Development
Status: Final
FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act: Guidance for Industry
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).
Download the Guidance Document
