he Drug Submission Review Performance Reports provide detailed metrics about the timeliness of pre-market drug review process against the performance service standards. The annual report compares five calendar years, while the quarterly report compares five quarters. The reports are broken down by operational areas. The Therapeutic Product (TPD) Report covers pharmaceuticals, while the Biologic and Therapeutic Products Directorate (BGTD) Report covers biologics. Within each report, statistics are provided by submission type and show the number received, the number in workload, the number of decisions and the number of approvals and time to approval.
Submissions Received are counts of submissions received during the year using from the filing date. Workload is reported as the number of submissions "under active review" on a given day. "Backlog" is the proportion of the workload that is over target. Approvals are Notice of Compliances (NOC) issued or issuable. A NOC issuable is when a submission's NOC is placed "on hold" awaiting authorization to market, due to Patent regulations or due to de-scheduling (from prescription to Over the Counter).
For More Information please Click: Drug Submission Performance Reports
No comments:
Post a Comment