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. 1001. Beau Biden Cancer Moonshot and NIH innovation projects. Annual appropriation of funds into the NIH Innovation Account (FY17-26), and subsequent allocation to specific initiatives: PMI (FY17-26), BRAIN (FY17-26), Cancer Moonshot (FY17-23), and regenerative medicine (FY17-20).
In addition, requires NIH to submit a work plan to Congress by June 12, 2017 for the NIH Innovation Projects and to solicit input from the public prior to submitting the work plan.
Further directs NIH to submit an annual report to Congress by October 1st of each fiscal year 2018 – 2027 outlining the amount of money obligated as well as a description of the projects and how they are advancing.

10/6/2017: NIH announced the FY 2017 funded awards through the NIH Regenerative Medicine Innovation Project

9/13/2017: Work plan submitted to Congress. Further information on 21st Century Cures page of the NIH Website. The work plan and strategic plan are also available. 

3/28/2017: The Advisory Committee to the Director of NIH held a conference call to discuss the draft work plans outlined in this section. The meeting was announced in a federal register notice. It provided an overview of implementation and provided an update on work plans for each of the following: Cancer Moonshot Initiative, Regenerative Medicine, Precision Medicine Initiative, BRAIN Initiative

20171006 10/06/2017 Funding, NIH, Regenerative Medicine
fa fa-2x fa-long-arrow-right Sec. 3035. Report on regenerative advanced therapies. 3/1/2017 (and every year thereafter): requires HHS to submit a report to Congress on the number and type of applications for regenerative advanced therapies.

4/5/2018: CBER reported to Congress on the number and type of applications for regenerative advanced therapies.

20180405 04/05/2018 FDA, Regenerative Medicine, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3036. Standards for regenerative medicine and regenerative advanced therapies. 12/13/2017: instructs HHS to review regulations and guidance relevant to regenerative advanced therapies; and, through a public process, update such regulations and guidance as the Secretary determines appropriate.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Guidances, Regenerative Medicine, Regulatory Affairs
fa fa-2x fa-binoculars Sec. 3033. Accelerated approval for regenerative advanced therapies. Authorizes FDA to designate certain products as Regenerative Medicine Advanced Therapies, making them eligible for increased and earlier interactions with FDA.

2/15/2019: FDA released the "Expedited Programs for Regenerative Medicine Therapies for Serious Conditions: Guidance for Industry," offering recommendations on the expedited development and review of regenerative medicine therapies for serious conditions.

FDA has articulated the eligibility criteria for a drug to receive RMAT designation and the process to submit a request. For more, please see this March 21, 2017 FDA voice blog post.

CBER Director reflects on how RMAT designation will speed approval at the May 2017, Food & Drug Law Institute Annual Conference. (See more here


20190225 02/25/2019 Regenerative Medicine
fa fa-2x fa-check Sec. 3034. Guidance regarding devices used in the recovery, isolation, or delivery of regenerative advanced therapies. 12/13/2017: requires issuance of draft guidance clarifying how, in the context of regenerative advanced therapies, the Secretary will evaluate devices used in the recovery, isolation, or delivery of regenerative advanced therapies.

2/19/2019: FDA announced the availability of a final guidance entitled "Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Guidance for Industry," fulfilling a statutory requirement of this section.

11/17/2017: FDA announced the availability of the draft guidance entitled “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry.

20190220 02/20/2019 Regenerative Medicine


Send us your feedback and updates