Secrets of a Successful Product Review: Get Inside FDA’s Head and Do Your Homework
Posted 01 May 2010 | By
It is true that FDA is asking many more questions about applications and requesting additional clinical data, at times at the end of a long review. These requests can delay the approval/clearance process and sometimes lead companies to consider pursuing marketing authorization outside the US first. FDA is overworked and underfunded, and it appears there are times when the agency does not complete its review in a timely manner, does not review the application as completely as one might hope, does not provide timely comments to allow the process to move forward, or seeks more time by asking for additional information.