Day: February 16, 2023

FDA approval of a new drug is often touted as a gold standard for regulatory approval for that drug. However, about 50% of the times, regulators in Canada, Europe, Australia and the United Kingdom, rejected the approval of that same drugs due to insufficient benefit or unreasonable risk. Most of the drugs rejected by other … Read more

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 … Read more