Breakthrough Therapy: 'A Lower Bar Of Evidence'?
MedPAC meeting elicits negative view of designation from one members and no one disagreed. Should US FDA reiterate what the special designation actually means?
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A project to validate a depression severity measurement tool that employs artificial intelligence for use in drug trials is moving forward at FDA. The milestone is a sign of things to come – and of the incremental process for AI adoption by the regulator.
In US FDA’s draft, mandated by in the current user fee legislation, contract manufacturers can also vie for a designation. CDER ETT and CBER CATT teams will play a key role in the process.