Anavex Life Sciences Corp (AVXL)

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This has also provided cover for BP to abandon (except BIIB) AD trials based on Amyloid...

This shift to smaller review divisions should reduce bottlenecks in the review process, she explained at the annual meeting of the Food and Drug Law Institute (FDLI) last week in Washington, D.C. An OND reorganization steering committee heads up the effort, and, she emphasized, the review program modernization effort is “proceeding according to plan.”
Commissioner Scott Gottlieb similarly highlighted how OND modernization will help FDA adapt to important scientific changes in medicine. The overall aim, he explained in a keynote speech at the FDLI meeting, is to better align new drug development and review with new types of medicines designed to target molecular changes that initiate disease, and “not just the symptoms of illness.” This shift will require new approaches to documenting and evaluating applications, including a team-based review process that brings together staff with expertise in areas such as statistics, modeling, simulation, and advanced manufacturing to assess novel trial designs and drug development approaches.