Newsletter - February 16, 2023
About Half of the New Drugs Approved by FDA Are Not So by Other Countries
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...Read More
FDA’s Guidance on Neonatal Product Testing Highlights Their Impossibility
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...Read More
About Half of the New Drugs Approved by FDA Are Not So by Other Countries
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...Read More
FDA’s Guidance on Neonatal Product Testing Highlights Their Impossibility
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...Read More
