The FDA's Center for Devices and Radiological Health has set personalized medicine as one of its priorities for the current year, aiming for draft guidance on co-development of drugs and diagnostics by year's end.
In CDRH’s 2012 Strategic Priorities document, priority four is to proactively facilitate innovation and address unmet public health needs, anticipating emerging technological trends and public health challenges and partnering with federal and external stakeholders to facilitate the development of innovative, safe and effective medical devices and advance regulatory science.
Within this priority, one of CDRH’s strategies is to further develop a personalized medicine program. It will work collaboratively with federal government partners and external constituencies to assure the appropriate regulatory oversight of therapeutics and diagnostics when their safety and effectiveness are intimately tied to one another.
The center’s goals include continuing to develop policies and procedures to assure that safe and effective diagnostic products are either innovative themselves or provide innovative uses reach the public. By June 30, 2012, CDRH plans to clear final guidance on Companion Diagnostics. By Dec. 31, 2012, CDRH plans to clear draft guidance on co-development of drugs or biologics and devices.