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GUIDANCE DOCUMENT

General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry July 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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

Submit Comments by 10/30/2019

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2019-16375


Docket Number:
2019-16375
Issued by:
Guidance Issuing Office
Center 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This draft guidance is intended to assist sponsors of new drug applications (NDAs), biologics license applications (BLAs), and supplements who are planning to conduct clinical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 This guidance supplements the FDA draft guidance entitled General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products (December 2014), as it addresses general clinical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 The issuance of this draft guidance on clinical pharmacology considerations for neonatal studies for drugs and biological products is required under section 505(d)(2) of the FDA Reauthorization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).