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.
FDA has initiated the approval of leucovorin calcium tablets, rushing them to market as part of a push from the Trump administration to identify potential treatments for autism spectrum disorder.
