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The Rise of Real-World Evidence in Regulatory Strategy, Part 3: RWE in Accelerated Approvals
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In this third part of our series in collaboration with A nalysis Group , Wayne chat s with Dr. Mar al DerSarkissian, Managing Principal at Analysis Group; Dr. Mark Robbins, President and CEO of Kodiak Strategic Consultants; and Bethany Hills, Regulatory Partner at White & Case . Together, they discuss expedited FDA drug development and review pathways; accelerated approval and its value to sponsors and investors; surrogate endpoints and their role in accelerated approval; the Food and Drug Omnibus Reform Act and FDA's expanded accelerated approval authorities; FDA's evolving current evidentiary standards for accelerated drug approvals; RWE in accelerated approval strategies; FDA…