Delivering Promising New Medicines Without Sacrificing Safety and Efficacy
All drugs approved under FDA's expedited programs are held to the same approval standards as other FDA drug approvals. Learn more about Fast Track, Breakthrough Therapy, Regenerative Medicine Advanced Therapy, and Priority Review designations, and Accelerated Approval in this FDA Voices post by Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research.
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