FDA Device and Drug Chiefs Push Informed, Robust Patient Engagement

FDA device center chief Jeff Shuren said he plans to launch a patient engagement advisory panel to help the agency craft new regulatory policies, such as regulations for laboratory developed tests. But he also warned that patients need to make sure they are informed before they start weighing in, noting that some groups are airing concerns based on misinformation. The agency's top drug official Janet Woodcock also suggested that patient-developed tools like surveys on risks versus benefits can be valuable...