Stakeholders Craft Patient Engagement Paper In Bid To Steer FDA Policy

The National Health Council (NHC) and Genetic Alliance (GA) are drafting a proposal they hope will steer FDA's development of guidance on ways to formally engage patients in the drug development process. The groups unveiled an initial outline last week that calls for FDA to voice strong support for patient engagement, and to define key terms and guide rails for appropriate interaction between drug sponsors and patients during the development process. The outline is the product of a December meeting...