Day: December 7, 2023

Starting this week, the Premarket Approval (PMA) applications can also be submitted electronically to the FDA using the eSTAR format. FDA released an update of the eSTAR template which now includes the PMA application. It is critical to review the utility of the eSTAR template for creating FDA-acceptable PMA applications. The eSTAR template is a … Read more

According to the FDA, all clinical trials that should be compliant with the clinicaltrials.gov regulations are already compliant. In a surprising blog this week, the FDA Commissioner pointed out the major flaw in the complaint that most clinical trials are not compliant with clinical trial reporting requirements by stating that only 15% of the trials … Read more