GDUFA IV Negotiation Session Minutes
The ongoing GDUFA IV negotiations have shed some light on interesting issues that will apply to the new GDUFA reauthorization period for FYs 2028 to 2032 presently being considered by both industry and the FDA. The full minutes of the February 19, 2026 FDA-industry negotiation meeting can be found here, but I have a brief summary of the […]
