21st Century Cures

The 21st Century Cures Act (P.L. 114-255) is landmark, bipartisan legislation that was signed into law on Dec. 13, 2016, and touches virtually all aspects of biomedical research, medical product development and the regulatory approval process. Read what FasterCures has said about 21st Century Cures over the years.

FasterCures worked closely with Congress, federal agencies and the advocacy community throughout the legislation’s journey to the president’s desk. In February 2017, we debuted the 21st Century Cures Tracker to track the implementation of the 100+ sections in Division A, which include the key provisions relevant to biomedical research and innovation. (Other divisions of the law pertain to mental health and Medicare; since those are not areas of focus for FasterCures, we will not be actively tracking them here.) Learn more about how to use the tracker with our FAQs page.

A few examples of the issues we will be tracking include the impact of changes to the National Institutes of Health’s administrative requirements for grantees, how the Food and Drug Administration implements new changes designed to enhance patient engagement and how the Department of Health and Human Services is using its new authorities to promote health information technology interoperability.

Many external factors will affect the progress of these initiatives, including policies related to hiring freezes and uncertain funding levels. This tracker is not meant to be a pass/fail report card, but rather a snapshot in time that can help explain impact and identify where progress is needed.

Please keep coming back, as we will be updating the information regularly. Use the button below to send us feedback on the value of the information we are presenting, and the usability of this new resource.

Send us your feedback and updates

FasterCures' 21st Century Cures Act Tracker (P.L. 114-255)

Status Section Tracked Deadlines and Requirements Update Date of Update Tags
fa fa-2x fa-long-arrow-right Sec. 3011. Qualification of drug development tools. 12/13/2018: instructs FDA to convene a public meeting to solicit input on a new qualification process for biomarkers and other drug development tools.
12/13/2018: requires FDA to publish taxonomy on drug development tools for public comment. 1 year after close of comment period taxonomy must be finanlized.
12/13/2019: directs FDA to issue draft guidance on this qualification process.
12/13/2021: directs FDA to release a report which describes the use of, and success of, this new qualification process.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, Guidances, Medical Product Development, Regulatory Affairs, Reports
fa fa-2x fa-binoculars Sec. 3013. Reauthorization of program to encourage treatments for rare pediatric diseases. Reauthorizes the pediatric rare disease priority review voucher program until 2020. FasterCures will periodically update based on the implementation and use of the voucher program. 20161213 12/13/2016 FDA, Medical Product Development, Rare Disease, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3014. GAO study of priority review voucher programs. 12/31/2020: requires GAO to issue report evaluating the three Priority Review Voucher (PRV) programs: Neglected Tropical Disease, Rare Pediatric Disease, and Medical Countermeasure. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, GAO, Medical Countermeasures, Medical Product Development, Rare Disease, Regulatory Affairs
fa fa-2x fa-check Sec. 3016. Grants for studying continuous drug manufacturing. Allows the FDA to issue grants to further the study of continuous manufacturing for drugs. Complete. 20161213 12/13/2016 FDA, Funding, Medical Product Development
fa fa-2x fa-long-arrow-right Sec. 3021. Novel clinical trial designs. 6/13/2018: directs FDA to host a public meeting to discuss the incorporation of complex adaptive and other novel trial designs into clinical protocols and new drug applications.

12/13/2019: requires FDA to issue draft guidance addressing the use of complex adaptive and other novel trial design in the development of new drugs or biologicals; within 1 year after the public comment period closes, FDA finalization of such guidance.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 Clinical Trials, FDA, Guidances, Medical Product Development, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3084. Medical countermeasures innovation. 12/13/2020: requires GAO publication of a review of medical countermeasure innovation program established by this provision. The program will sunset on 9/30/2022.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 BARDA, GAO, HHS, Medical Countermeasures, Medical Product Development, Reports
fa fa-2x fa-long-arrow-right Sec. 3022. Real world evidence. 12/13/2018: requires FDA to develop and begin to implement, a framework to evaluate the use of real world evidence to help support the approval a new indication for a for a previously approved drug, or to support post-approval study requirements.

12/13/2021: requires FDA to issue draft guidance based on implementation and use of RWE framework which describes circumstances where RWE may be relied upon and appropriate standards and methodologies for collection and analysis of RWE; by 18 months after the above comment period closes finalization of guidance.

7/31/2017: FDA announced  a public workshop, "A Framework for Regulatory Use of Real-World Evidence” convened by the the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA. The purpose of the public workshop is to bring the stakeholder community together to discuss a variety of topics related to the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulatory decision making.

20161213 12/13/2016 FDA, Guidances, Medical Product Development, Regulatory Affairs

 

Send us your feedback and updates