Posted by Michael Wonder on 12 Dec 2019
FDA issues draft guidance to foster oncology product development for paediatric populations
12 December 2019 - Today, the U.S. FDA issued a draft guidance document, “FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act.”
The draft guidance addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs for which original new drug applications (NDAs) and biologics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The draft guidance provides the pharmaceutical industry, clinical investigators and institutional review boards with information to facilitate paediatric studies of molecularly targeted oncology drugs.
