The US Food and Drug Administration (FDA) on Friday issued a draft guidance to assist sponsors in determining the need to conduct long-term neurodevelopmental studies to support the safety of drugs, biologics and devices used in neonatal populations. Such studies, said FDA “will help ensure a safer product.”
The guidance addresses factors for determining when it is necessary to conduct a long-term safety study, how to develop a safety study and what to measure in these evaluations. The guidance does not address efficacy of products intended to improve neurologic outcomes.
The guidance was developed by the FDA’s Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), as well as the Office of Pediatric Therapeutics (OPT).
FDA notes that Congress has enshrined incentives for pediatric drug development under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), which were made permanent under Title V of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA)…
