FDA sets out its meeting management plans

WASHINGTON - FDA has issued a draft guidance outlining procedures for meetings at CDER and CBER to address drugs and biologics covered by the Prescription Drug User Fee Act (PDUFA).

The draft document, "Formal Meetings with Sponsors and Applicants for PDUFA Products", implements provisions of the Food and Drug Administration Modernization Act and an agreement between the agency and industry over terms under which user fees are paid for product reviews...