FDA Updates Drug Development Tool Qualification Process
The 21st Century Cures Act added a new section to the Federal Food, Drug, and Cosmetic Act on Qualification of Drug Development Tools that established an updated multi-stage process for drug development tool qualification. In an online notice, FDA says the process includes three submission milestones — Letter of Intent, Qualification Plan, and Full Qualification Package.
The new section also includes transparency provisions that apply to requestors’ submissions and the agency’s formal written determinations in response to such submissions. FDA says that consistent with the transparency provisions, it plans to publicly post information contained in a table in the notice listing information requirements for each of the three milestones. It also says it will be using a phased approach to move from the legacy qualification process to the new process.