General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry

Comments and suggestions regarding this draft document should be submitted by October 30, 2019

This draft guidance is intended to assist sponsors of new drug applications (NDAs), biologics license applications (BLAs), and supplements who are planning to conduct clinical studies in neonatal populations. This guidance supplements the FDA draft guidance entitled General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products (December 2014), as it addresses general clinical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, a pediatric subpopulation. The issuance of this draft guidance on clinical pharmacology considerations for neonatal studies for drugs and biological products is required under section 505(d)(2) of the FDA Reauthorization Act of 2017 (FDARA).

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