Newsletter - September 2, 2021
FDA: No Need to Re-Monitor Remote Clinical Trials
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...Read More
FDA Start Online 510K-Review Tracker
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...Read More
FDA: No Need to Re-Monitor Remote Clinical Trials
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...Read More
FDA Start Online 510K-Review Tracker
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...Read More
