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12/13/2019: directs FDA to issue draft guidance on this qualification process.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

12/16/2019: FDA announced the issuance of a draft guidance entitled "Qualification Process for Drug Development Tools--Guidance for Industry and FDA Staff." Public commentary is requested and may be submitted electronically by February 14, 2020.

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.

20191216 12/16/2019 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.

7/30/2019: FDA announced the availability of a draft guidance entitled "Rare Pediatric Disease Priority Review Vouchers," providing information on the rare pediatric disease priority review voucher program. Comments on the draft guidance may be submitted electronically by September 30, 2019.

12/7/2017: FDA announced the availability of draft guidance entitled "Pediatric Rare Diseases-A Collaborative Approach for Drug Development Using Gaucher Disease as a Model"

20190730 07/30/2019 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.


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.

9/30/2018: FDA initiated a pilot program to help drug developers use complex innovative trial designs, an element of the most recent PDUFA agreement.

8/29/2018: FDA launched a pilot program, the "Complex Innovative Designs Pilot Meeting Program," which provides drug and biologic companies the opportunities to discuss the use of novel complex innovative trial designs (CID) with agency staff for their clinical development programs.

3/20/2018: FDA held a public meeting entitled, "Promoting the Use of Complex Innovative Designs in Clinical Trials" with meeting materials and information now available on the FDA website. 

20180930 09/30/2018 Clinical Trials, FDA, Guidances, Medical Product Development, Regulatory Affairs
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 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.

7/9/2019: FDA announced a public meeting entitled "Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs" to be held on July 16th. The meeting will discuss the incorporation of real-world evidence in proposed clinical investigation protocols and applications for new animal drugs.

6/10/2019: The Robert J. Margolis, MD, Center for Health Policy at Duke University announced the convening of a public workshop to consider key challenges and opportunities to establish a more systematic approach to collecting and submitting real-world data to FDA as part of evidence packages.

5/9/2019: FDA announced the availability of a draft guidance for industry entitled "Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics." Comments on the guidance may be submitted electronically until July 8, 2019.

12/6/2018: FDA released a new strategic framework for their real-world evidence program, fulfilling a requirement for this section.

11/6/2018: FDA launched the MyStudies App to collect real-world evidence from patients' mobile devices to help inform regulatory decisions around medical products.

7/31/2017: FDA announced a public workshop, "A Framework for Regulatory Use of Real-World Evidence” convened by 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.

20190709 07/09/2019 FDA, Guidances, Medical Product Development, Regulatory Affairs


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