The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.
The law builds on FDA's ongoing work to incorporate the perspectives of patients into the development of drugs, biological products, and devices in FDA's decision-making process. Cures enhances our ability to modernize clinical trial designs, including the use of real-world evidence, and clinical outcome assessments, which will speed the development and review of novel medical products, including medical countermeasures.
It also provides new authority to help FDA improve our ability to recruit and retain scientific, technical, and professional experts and it establishes new expedited product development programs, including:
- The Regenerative Medicine Advanced Therapy, or RMAT, that offers a new expedited option for certain eligible biologics products.
- The Breakthrough Devices program, designed to speed the review of certain innovative medical devices.
In addition, the Cures Act directs FDA to create one or more intercenter institutes to help coordinate activities in major disease areas between the drug, biologics and device centers and improves the regulation of combination products.
FDA is working hard to maximize the authorities and resources Congress granted us in Cures, as FDA Commissioner Scott Gottlieb outlined in an FDA Voice Blog.
The Cures Act authorized $500 million over 9 years to help FDA cover the cost of implementing the law. We developed a draft work plan showing how FDA would use that funding, subject to annual appropriations. In keeping with the statutory requirements, we submitted the draft work plan to FDA’s Science Board for their comments and recommendations at a public meeting in May. The final work plan, which includes the recommendations from the Science Board, was delivered to Congress on June 9.
- Submission to Congress: Food & Drug Administration Work Plan and Proposed Funding Allocations of FDA Innovation Account (PDF - 233KB)
Required by Section 1002 of the 21st Century Cures Act (Public Law 114-255)
Resources For You
- 21st Century Cures Act (Congress.gov)
- Technical Corrections include also in FDA Reauthorization Act of 2017 (FDARA) (Congress.gov)