www.fdanews.com/articles/188428-fda-gives-feedback-to-congress-on-new-diagnostics-standards
FDA Gives Feedback to Congress on New Diagnostics Standards
September 17, 2018
FDA Commissioner Scott Gottlieb said the agency has advised Congress to take a three-pronged approach to modernizing diagnostics standards.
The agency has proposed a regulatory framework based on a few key principles, Gottlieb said in remarks at the Friends of Cancer Research’s 7th Annual Blueprint for Breakthrough Forum in Washington, D.C.
Gottlieb said regulatory agencies and policymakers should take a consistent approach for all in vitro clinical tests regardless of whether they are developed by a traditional manufacturer or a clinical laboratory.