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. 2041. Task force on research specific to pregnant women and lactating women. 3/13/2017 (90 days): requires establishment of a "Task Force on Research Specific to Pregnant Women and Lactating Women;" 18 months after establishment of task force (by 6/13/18 ) -- requires Task Force submission of a report to Congress.

12/13/2018: requires HHS to update regulations and guidance, as appropriate, regarding the inclusion of pregnant women and lactating women in clinical research.

10/1/2018: The Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) submitted final recommendations for research on therapies used by pregnant and lactating women.

2/27/2018: February 26 & 27, 2018 PRCG hosted meeting with full meeting materials provided. 

11/7/2017: November 6 & 7, 2017 PRGLAC hosted the second meeting and supplied full meeting materials for public consumption. 

10/2/2017: An updated notice was published for the meeting of the Task Force on November 6-7, 2017

8/22/2017: On August 21 & 22, 2017, Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) hosted it's first meeting and supplied full meeting materials for public consumption. 

4/18/2017: the Federal Register published a meeting notice for the Task Force which will be August 21 & 22, 2017 and a second meeting will be November 6-7, 2017 

3/21/2017: the NIH formally announced the establishment of the task force within the Eunice Kennedy Shriver National Institute of Child Health and Human Development. NICHD has reported to us that it is now in the process of compiling the slate of nominees to serve on the taskforce for the Secretary’s consideration.

1/18/2017: The Secretary of HHS delegated authority to the NIH to establish this task force.

20181001 10/01/2018 CDC, FDA, Guidances, NIH, Regulatory Affairs, Reports, Research
fa fa-2x fa-long-arrow-right Sec. 2063. Accessing, sharing, and using health data for research purposes. 12/13/2017: requires HHS issuance of guidance clarifying that remote access of health data by researchers (under appropriate circumstances) is not forbidden by regulation.
12/13/2017: requires HHS issuance of guidance clarifying requirements for the authorized disclosure of protected health information for research.
12/13/2017: requires HHS establishment of a "Working Group on Protected Health Information for Research" to study and, within 1 year of establishment, report on whether the uses and disclosures of protected health information for research purposes should be modified.
12/13/2017: requires submission of a report to the HHS Secretary

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 CDC, Data Sharing, FDA, Guidances, HHS, NIH, Regulatory Affairs, Reports, Research
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

6/13/2018: FDA announced 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"

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.

20180613 06/13/2018 FDA, Guidances, Patient Engagement, Regulatory Affairs
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.

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.

20181031 10/31/2018 FDA, Guidances, Medical Product Development, Regulatory Affairs, Reports
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.

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. 

20180320 03/20/2018 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 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
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-long-arrow-right Sec. 3038. Combination product innovation. Contains a number of elements designed to improve the regulation and review of combination products, including issuing guidance by 12/13/2020 that describes the process for managing pre-submission interactions, best practices for ensuring that feedback represents FDA's best advice, and information on meetings between the sponsor and FDA.

6/13/2018: FDA announced the availability for comment of a list of alternative or streamlined mechanisms for complying with the current good manufacturing practice (CGMP) requirements for combination products. 

20180613 06/13/2018 FDA, Guidances, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3052. Humanitarian device exemption. 6/13/2018: requires FDA to issue a guidance document define "probable benefit" in the context of the humanitarian device exemption.

6/13/2018: FDA issued draft guidance on Humanitarian Device Exemption (HDE) Program

6/7/2017: FDA rule notice in the Federal Register: section 3052 of the 21st Century Cures Act amended section 520(m) of the FD&C Act to allow for HDE approval for devices that, among other things, treat or diagnose a disease or condition that affects “not more than 8,000” individuals in the United States; this threshold had been “fewer than 4,000” individuals in the United States (amending 21 U.S.C. 360j(m), passim). This final rule amends part 814 (21 CFR part 814) in several places to accurately reflect the threshold recently enacted into law.

20180613 06/13/2018 FDA, Guidances, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3053. Recognition of standards. Instructs FDA to review and update its guidance on submission and evaluation of independent standards for medical device review.

9/14/2018: FDA announced the availability of a draft guidance titled "Recognition and Withdrawal of Voluntary Consensus Standards" which updates published guidance topics covered in section 3053.

9/22/2017: FDA noted on its tracker of 21CC deliverables that, "provided training to FDA employees who review premarket submissions for devices on use of recognized standards for purposes of meeting a premarket submission requirement or other applicable requirement."

20180914 09/14/2018 FDA, Guidances, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3057. CLIA waiver improvements. 12/13/2017: instructs CMS to issue draft guidance on CLIA waiver improvements, and issuance of final guidance within one year after comment period closes.

11/29/2017: FDA announced the availability of the draft guidance entitled “Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” Comments on the draft guidance must be submitted by 1/29/2018. .

20171129 11/29/2017 CMS, FDA, Guidances, Medical Devices, Regulatory Affairs


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