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Guidance Issuing OfficeCenter for Drug Evaluation and Research
This draft guidance is intended to assist sponsors of new drug applications (NDAs), biologics license applications (BLAs), and supplements who are planning to conduct clinical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 This guidance supplements the FDA draft guidance entitled General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products (December 2014), as it addresses general clinical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 The issuance of this draft guidance on clinical pharmacology considerations for neonatal studies for drugs and biological products is required under section 505(d)(2) of the FDA Reauthorization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).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2019-D-3132.