Included in the many provisions contained in the 21st Century Cures Act are ones addressing drug, device, and biologic development and approval. Topics include the use of “real world evidence” in regulatory approvals, drug development tools like biomarkers, review of drugs for patient subpopulations with unmet medical needs, continuous manufacturing, clinical trial design and more. This briefing focuses on these major drug, device, and biologic development and approval provisions contained in the Cures Act.
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