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.

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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12/13/2019: directs FDA to issue draft guidance on this qualification process.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.

7/25/2019: FDA announced the establishment of a public docket to receive comments from interested parties on the taxonomy for the classification of biomarkers for use in drug development. Public commentary is requested and may be submitted written or electronically by September 23, 2019.

12/12/2018: The FDA announced a draft guidance on considerations to address when developing a biomarker, entitled "Biomarker Qualification: Evidentiary Framework." Public commentary on the guidance is requested and may be submitted written or electronically by February 11, 2019.

11/13/2018: The FDA announced a public meeting titled "Drug Development Tool Process under the 21st Century Cures Act and PDUFA VI" that will provide an opportunity for public input regarding the drug development tools qualification pathway for animal models, biomarkers, and clinical outcome assessments. Public commentary is requested and may be submitted written or electronically through the public docket until January 31, 2019.

10/30/2018: The FDA is seeking feedback on the surrogate endpoint table (SE table) to help determine its utility and to assist in developing future versions of the table. Comments must be submitted written or electronically by December 31, 2018.

7/25/2018: The FDA has fulfilled a requirement of Section 3011 with the publishing of the Surrogate Endpoint Table. This table is a list of "surrogate endpoints which were the basis of approval or licensure (as applicable) of a drug or a biological product" under both accelerated and traditional pathways. The endpoints can be used instead of clinical outcomes in some clinical trials, which has helped expedite drug development.

20190725 07/25/2019 FDA, Guidances, Medical Product Development, Regulatory Affairs, Reports
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


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