CDER Targets Generics in Planned Guidance Agenda
CDER announced plans to publish almost 90 guidances in 2020 including 20 related to generic drugs.
The center’s guidance agenda includes a revised generic guidance focused on 180-day exclusivity. CDER also plans on issuing new guidances on the Orange Book and on three-year exclusivity determinations.
The center plans to publish two new guidances explaining when it will refuse to receive drug master files (DMFs).
CDER also anticipates releasing 12 procedural guidances, including new guidance on civil monetary penalties drugmakers face for failing to meet accelerated postmarketing requirements.
In addition, the FDA plans on releasing 11 new guidances on chemistry, manufacturing and controls.