Drugs

Neonatal Study Considerations Guidance

FDA has published a draft guidance, General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products, to assist sponsors of NDAs, BLAs, and supplements who plan to conduct clinical studies in neonatal populations. The document says the guidance supplements a 2014 draft guidance on general clinical pharmacological considerations for pediatric studies for drugs and biological products as it addresses general clinical pharmacology considerations in neonates, a pediatric subpopulation. Issuance of this draft guidance was required by the FDA Reauthorization Act of 2017.

The guidance does not discuss the timing to initiate neonatal studies. Questions about the appropriate timing for starting such studies should be discussed with the relevant FDA review division, it says.

Contents of the document include Introduction, Background, Definitions and Subgroup Classifications, General Considerations (pharmacokinetics, pharmacodynamics, pharmacogenomics), and Study Design Considerations (general approaches to providing substantial evidence of safety and effectiveness in neonates, study population, dose selection, formulation, sample size, sampling, bioanalytical methods, data analysis, clinical study report, data submission, ethics).

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