At the FDA Law Blog, Jamie K. Wolszon & Jeffrey N. Gibbs of Hyman Phelps provided an extended summary of the November 6 FDA-CDC public workshop on the FDA's plan to regulate laboratory developed tests. Their report is here. "OIR Head Alberto Gutierrez Discusses Draft LDT Framework at Federal Laboratory Advisory Committee Meeting; Provides Additional Insights on Agency Plans to Regulate LDTs."
For those with access, Genomeweb provided a detailed report previewing the Association for Molecular Pathology "Visit the Hill" day this week, focusing on the AMP's position on LDT regulation....here. Turna Ray writes: "Following Republican Election Gain, Detractors of FDA Lab Test Regulation Seize Chance for Support."