The European Medicines Agency (EMA) and MIT’s Center for Biomedical Innovation (CBI) and Center for International Studies (CIS) are launching a collaborative research project with a focus on enhancing regulatory science in pharmaceuticals.
Specific questions addressed by this project include how to:
* adapt current regulatory requirements to support the efficient development of safe and effective drugs;
* incorporate patient valuation of health outcomes and benefit-risk preferences into regulatory decision-making;
* implement 'staggered' and 'progressive' approaches to drug approval;
* improve fulfillment of post-marketing regulatory requirements.
The project will explore the feasibility of, priorities for and practical considerations of implementing demonstration projects on some of the issues addressed during the course of the research.
Sound familiar? It's what the FDA's Critical Path program was designed to do -- that is until it hit Congressional treacle embodied by a certain member who will shortly lose her majority status.
The data and recommendations from this project are expected to link to implementation of the Agency's Roadmap to 2015 and the CBI's New Drug Development Paradigms (NEWDIGS) research program.
The project is scheduled to be completed by December 2011.
Hopefully with a new chair at the helm of the House Agriculture (and FDA) Appropriations Committee, funding for the Reagan/Udall Center can be released and FDA can, once again, take a leadership role in developing the tools for 21st century regulatory science.
