"This session will provide insights into FDA's changing regulatory approach to in vitro diagnostics. Panelists will focus on critical emerging issues in the agency's draft guidances on IVDMIAs and ASRs, as well as on congressional oversight and legislative proposals affecting personalized health care, genetic testing, home tests and direct-to-consumer tests. Attendees will benefit from the insights of leading industry experts as well as congressional staff concerning the future direction of FDA regulation."

Objective1:Provide a timely update on rapidly changing developments in FDA 's views (and that of Congress) of molecular diagnostics and how they are regulated.

Objective2:Create a unique opportunity to question FDA , industry, congressional and academic experts on critical issues.

Objective3:"Address important substantive issues that cut across diagnostic and screening, as well as therapeutic and
pharmacogenomic, product development."