Neonatal Study Pharmacology Considerations

FDA has published a guidance, General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products, to assist sponsors of INDs, NDAs, and BLAs and their supplements who are planning to conduct clinical studies in neonatal populations. The document has recommendations for neonatal clinical pharmacology studies, whether they are conducted under Section 505A of the Federal Food, Drug, and Cosmetic Act, Section 505B of the act, or neither.

“Effectiveness, safety, or dose-finding studies in neonates involves assessing clinical pharmacology information, such as information regarding a product’s pharmacokinetics and pharmacodynamics to inform dose selection and individualization,” the guidance says. “As such, the general considerations described in this guidance apply to any neonatal studies which incorporate pharmacology assessments. This guidance does not discuss the timing to initiate neonatal studies.”