Wednesday, November 12, 2014

FDA Law Blog: Summary of November 6 CDC-FDA meeting on LDT regulation

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  Turna Ray writes:  "Following Republican Election Gain, Detractors of FDA Lab Test Regulation Seize Chance for Support."