FDA Unveils Guidances On Next-Gen Clinical Trials, Rare Disease Drugs

By David Roza / October 15, 2018 at 5:20 PM
FDA Commissioner Scott Gottlieb announced two new guidances Monday (Oct. 15) aimed at guiding industry on how to design clinical trials and medical products that use two new technologies: minimal residual disease (MRD) biomarkers and the tracking of molecular changes that cause diseases. The commissioner said the guidances are part of an agency effort to modernize its approach to clinical trial design and make the drug development process more efficient so that drugs can come to market more quickly. The...

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