FDA Patient Network’s Inaugural Meeting Seeks Input In Regulatory Decision-Making
This article was originally published in The Pink Sheet Daily
In the shadow of final negotiations over PDUFA reauthorization, the agency is inviting patients, their representatives, industry and academics to discuss how best to use patient input in decisions on regulated drugs, devices and biologics.
You may also be interested in...
Agency’s Patient Network Annual Meeting will help explain the drug development process along with agency and patient roles as part of ongoing effort to increase patient involvement.
PDUFA V framework to involve patients in the creation of the risk-benefit criteria for various diseases kicks off before the legislation is even enacted.
FDA is ready to bring patient voices and perspectives into the drug approval framework. Practically, that means that drug sponsors will have to develop new skills and structures for working with a familiar stakeholder group at an unfamiliar point in the drug development process. The new challenge was a major theme at PhRMA’s 2012 Annual Meeting.