Experts: Early Collaboration With FDA Critical To Aligning Drug-Dx Approvals

Companies developing companion drugs and in vitro diagnostics (IVD) should hold joint meetings with CDRH and the Center for Drug Evaluation and Research (CDER) as early as possible and ensure that drug and diagnostic development timelines are aligned, Linda Burdette, director of regulatory affairs at Hoffmann-La Roche, said Aug. 21 at the Cambridge Health Institute’s Regulatory Compliance in Drug-Diagnostic Co-Development conference.
Devices & Diagnostics Letter