IOM: FDA Needs Post-Market Muscle To Follow Biomarker-Based Approvals
This article was originally published in The Gray Sheet
Executive Summary
Congress should give FDA more authority to require post-market surveillance of medical products approved primarily based on surrogate endpoints, the Institute of Medicine recommends
You may also be interested in...
Two Reviews Question Quality Of Cardiac PMA Trials
Two recent studies question the consistency and quality of clinical trials intended to support FDA premarket approvals of cardiac devices. As one of the studies was conducted by agency scientists, new requirements for PMA studies may soon be in the offing
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.
Sanofi Skates To Where The Puck Is With Immunology
The French drugmaker has not abandoned oncology but has made it very clear that immunology and inflammation is the priority for its R&D euros.