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. 3001. Patient experience data. Requires FDA to include a statement regarding any patient experience data that was used at the time a drug is approved.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Patient Engagement, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3002. Patient-focused drug development guidance. 6/11/2017 (180 days): instructs FDA to develop a plan to issue draft and final versions of guidance documents regarding the collection of patient experience data, and the use of such data in drug development.
6/13/2018: requires FDA to issue a draft version of at least one such guidance identified in plan and within 18 months from close of public comment period, issue a final/ revised guidance.
12/13/2021: requires FDA to issued patient experience guidance documents

11/14/2019: FDA announced a public workshop to convene a discussion on incorporating clinical outcome assessments into endpoints for regulatory decision making. The public workshop will be held on December 6, 2019, from 9am-5pm at FDA's White Oak Campus.

10/1/2019: FDA announced the availability of a draft guidance entitled "Patient-Focused Drug Development: Methods to Identify What is Important to Patients," available for comment until December 30, 2019.

12/21/2018: FDA announced a draft guidance entitled "Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data," available for comment until March 21, 2019.

10/15/2018-10/16/2018: FDA held a public hearing on PFDD guidances, "Patient-Focused Drug Development Guidance: Methods to Identify What is Important to Patients and Select, Develop or Modify Fit-for-Purpose Clinical Outcome Assessments."

6/13/2018: FDA announced a draft guidance entitled “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input," available for comment.

3/19/2018: FDA held a public workshop "Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data"

12/18/2017: FDA held a public workshop on "Patient-Focused Drug Development: Guidance 1- Collecting Comprehensive and Representative Input," including issuing discussion documents. On June 12, 2018, FDA released the draft guidance.

10/27/2017: FDA announced a public workshop on "Patient-Focused Drug Development: Guidance 1 – Collecting Comprehensive and Representative Input" to take place 12/18/2017; registration will close on 12/10/2017. Meeting materials: Discussion Document , Attachment to Discussion Document: Appendices , Attachment to Discussion Document: Draft Standardized Nomenclature and Terminologies for the Series of FDA PFDD Guidances (Glossary)

9/8/2017: CDER announced a public workshop entitled “CDER Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development.” This public workshop builds upon previous CDER patient advocacy public workshops and is primarily for the rare disease community to help them effectively understand what FDA needs to enhance drug development. 

6/9/2017: FDA released the “Plan for Issuance of Patient‐Focused Drug Development Guidance” in accordance with this provision.

20191114 11/14/2019 FDA, Guidances, Patient Engagement, Regulatory Affairs
fa fa-2x fa-check Sec. 3003. Streamlining patient input. Exempts FDA from going through the Paperwork Reduction Act clearance process when requesting information from patients regarding their disease or treatments.


20161213 12/13/2016 FDA, Patient Engagement
fa fa-2x fa-long-arrow-right Sec. 3004. Report on patient experience drug development. 6/1/2021, 6/1/2026, and 6/1/2031: Requires FDA to periodically issue a report on FDA's use of patient experience data in regulatory decision-making, in particular with respect to the review of patient experience data and information on patient-focused drug development tools as part of approved applications.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Patient Engagement, Regulatory Affairs, Reports


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