Stakeholders Lobby Academic Medical Institutions To Back LDT Proposals

Both FDA and groups pushing competing legislative proposals for regulation of laboratory developed tests are holding discussions with academic institutions as a heated debate continues over the agency's oversight plan and legislative alternatives. While the academic community has remained largely on the sidelines of the flurry of lobbying activity, a few key medical universities are backing a proposal from a major pathology association. Last year FDA spurred debate on the issue by releasing a draft risk-based framework that brings laboratory...