FDA’s Guidance on Neonatal Product Testing Highlights Their Impossibility
(Thursday, February 16, 2023)
A new Guidance released this week describes the clinical testing requirements for products intended for treating neonatal diseases. Specifically, the guidance requires 2 years safety studies for neurologic, sensory, and developmental evaluations of new drugs, biologics or medical devices. While the guidance is obviously well-intentioned, it does raise doubts about the feasibility of such studies and if this requirement would discourage developers from going down that path in the first place. There is no doubt that any drugs used in neonates be extremely safe, and that adequate clinical evidence be collected before products are used in these most vulnerable patients. The guidance suggests tailoring the clinical evaluation to the type, timing in the life of a neonate, and duration of the exposure. There are several suggestions in the guidance for pragmatic clinical trials in neonates that anyone interested in such products should thoroughly review. These trials would be extremely hard to conduct and would raise several ethical and practical questions. The guidance emphasizes working with the parents, communities and physicians to create partnerships so such long-term trials can be completed practically. At the minimum, the guidance will help create comprehensive development plans for products intended for neonatal disease.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC