Multiple Test Algorithm Okay To Support Rapid HIV Test Approval - Panel
This article was originally published in The Gray Sheet
Executive SummarySponsors of rapid HIV test premarket approval applications should be allowed to use a multiple test algorithm to demonstrate sensitivity and specificity performance levels for diagnostic use, FDA's Blood Products Advisory Committee recommended at a June 15 meeting in Silver Spring, Maryland.
You may also be interested in...
Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.
Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza
The latest drug development news and highlights from our US FDA Performance Tracker.