FDA Calls for Long-Term Neonatal Safety Studies

The FDA highlighted the need for long-term neurodevelopmental studies by sponsors of neonatal medical products —whether a drug, biologic product, or device — in a new draft guidance released Friday.

Long-term follow-up is critical to assessing medical product safety in neonates, the agency said, adding that while adjunctive neurological assessments such as neuroimaging and electroencephalography may provide information on early safety concerns, “they cannot replace clinical assessments of long-term functional outcomes.”

Short-term safety evaluations typical for adults or other populations “may fail to identify important adverse effects in the neonatal population, as latent effects may follow early-life exposures,” the agency said.

The guidance also recommends inclusion of neonates in clinical trials initially developed for other populations, explaining that such studies “may be useful to establish dosing, safety, and efficacy or effectiveness.”