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Orphan Drugs Continue to Struggle During Approval Process

Average development time for orphan drugs that were first-in-class new molecular entities (NMEs) and that won U.S. Food and Drug Administration (FDA) approval between 1999 and 2012 was 18% longer than the average journey for all new drugs, says a new report from the Tufts Center for the Study of Drug Development (CSDD). Orphan […]

Kendall A. Marcus, MD, Director of the Division of Dermatology and Dental Products with the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration

FDA Encourages More Patient Input to Inform Reported Outcomes

In real estate it’s location, location, location. In clinical trials? Try patient, patient, patient. “Early patient input is critical on the road to patient-focused outcome treatment,” Kendall A. Marcus, MD, director of the Division of Dermatology and Dental Products with the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, told […]

Ken Getz

Are You Ready for the “Course Correction” in Clinical Trials?

Buckle up, because the clinical trial industry is on the cusp of seismic change that will “have a huge and profound impact on all of you and the work that you do,” Kenneth Getz, MBA, director of sponsored research programs and a research associate professor at the Tufts Center for the Study of Drug Development, […]