Day: September 2, 2021

Since the beginning of the pandemic, many clinical trials switched from conventional monitoring to remote monitoring for obvious reasons. Now that the pandemic related restrictions are easing, there is no need to re-monitor sites which had been remotely monitored according to the FDA. Remote monitoring or centralized monitoring has been a permitted format for monitoring … Read more

Starting this Monday, 30 August 2021, submitters of traditional 510(k) applications can directly track the progress of the review of their applications on FDA’s website via an online web-based tracker. This should allow applicants to plan their subsequent steps in marketing their product under review. The most common complaint from submitters of any application to … Read more