MDUFA VI

Innolitics partner David Giese, who has helped bring 35+ AI-enabled diagnostic devices to the US market, published a guide on FDA Pre-Submissions, noting that the FDA currently charges no fee for Pre-…

The FDA released the draft MDUFA VI commitment letter for FY2028–2032, introducing structural changes to how sponsors interact with the agency, including faster pre-submission feedback, a permanent au…