Outside Publication

What Pharma Companies Need to Know About FDA’s New Draft IVD Guidance, Applied Clinical Trials

February 12, 2018

Morgan Lewis partners Kathleen Sanzo and Michele Buenafe author an article detailing best practices for pharma and biotech companies in evaluating in vitro diagnostics (IVDs) risk and, if working with IVD partners, to develop processes to ensure the partner is also properly considering risk and filing appropriate regulatory documents consistent with clinical trial timelines.

Read the full Applied Clinical Trials article >>