US FDA Is Dedicating A 'Patient Affairs' Staff Without A Formal Reorg
The agency's principle deputy commissioner says it's creating a patient affairs staff, but will not undergo a reorganization.
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'Super Office' To The Rescue: FDA's Device Center Is About To Undergo A 'Total Product Life Cycle' Makeover
CDRH Director Jeff Shuren told industry that the device center is moving quickly to establish a "super office" to tackle the full spectrum of pre- and post-market issues to reduce inefficiencies to replace the more siloed approach. Chief Scientist Bill Maisel has already been named a director.
New office will develop agency-wide patient engagement policy and serve as entry point for patient groups new to FDA, but will not interfere with existing relationships between advocates and the drugs and biologics centers, FDA Commissioner Gottlieb says.
Will a meeting with the agency's new principal deputy commissioner help assure creation of new access point for patient engagement?