The Independent Expert Panel for Tobacco submitted its recommendations to Commissioner Robert Califf at FDA. The Operational Evaluation of FDA’s Tobacco Program was facilitated by the Reagan-Udall Foundation at the Commissioner’s request.
A federal judge ruled that the FDA lacks the statutory authority to regulate laboratory developed tests, finding squarely in favor of plaintiffs in the consolidated lawsuits brought by American Clinical Laboratories Association, Association for Molecular Pathology, and others. ASCP submitted an amicus brief supporting the plaintiffs.
