BRIEF—FDA issues draft guidance to boost cancer drug development for children

The US Food and Drug Administration (FDA) has issued a draft guidance document which addresses early planning for pediatric evaluation of certain molecularly-targeted oncology drugs.

These are products for which original new drug applications and biologics license applications  are expected to be submitted to the FDA on or after August 18, 2020, in accordance with section 505B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which was amended by the FDA Reauthorization Act of 2017 (FDARA).

The document is called the FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act, and can be accessed here.