FDA issues draft guidance for industry on General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products

FDA issues draft guidance for industry on General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products

Today, the U.S. Food and Drug Administration (FDA) issued a draft guidance for industry entitled “General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products.” This draft guidance assists sponsors of new drug applications (NDAs), biologics license applications (BLAs) for therapeutic biologics, and supplements who are planning to conduct clinical studies in neonatal populations. This guidance addresses the clinical pharmacology considerations for any planned studies in neonates. This is the first time the FDA is issuing a guidance specifically focused on neonates.

The guidance describes specific trial design considerations for developing a neonatal study plan and conducting neonatal pharmacology studies including study population, neonatal subgroup classification, dose selection, and study design and analysis. This guidance does not propose or otherwise represent any new FDA policies; it simply summarizes the FDA’s current scientific thinking.

This draft guidance supplements the FDA draft guidance entitled “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products” (December 2014), as it addresses general clinical pharmacology considerations in neonates.

The FDA encourages stakeholders to provide comments to public docket (docket number FDA-2019-D-3132).