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.

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Cures Act). It is hoped that provisions in the new bill, and the $6.3 billion it provides for medical research over the next decade, will spur innovation and new progress in medical treatments for the patients who need them.

This Client Briefing summarizes and analyzes the provisions in the Cures Act related to drug, device, and biologic development and approval. A companion Client Briefing focuses on provisions of the Cures Act that have not received as much attention but are equally significant, those affecting the Medicare and Medicaid programs. In addition, our recent blog post addresses the Cures Act provisions regarding mental health and substance abuse, and funding for combating opioid abuse.

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Client Alert 2016-325