EMEA, FDA Offer Opinions, Advice on Proposed Research Methods

The European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use can give drug developers a qualification opinion on specific uses of a proposed research method, such as biomarkers or new imaging methods, or qualification advice on future protocols and methods, according to a final guidance. EMEA opinions are public documents while advice remains confidential. Applicants may submit requests for opinions or advice to the FDA or Japan’s Pharmaceuticals and Medical Devices Agency simultaneously with the EMEA application.
Drug Industry Daily