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. 1002. FDA innovation projects. Annual appropriation of funds into the FDA Innovation Account (FY17-25)
6/11/2017 - Requires submission of a work plan for the FDA Innovation Fund

7/7/2017: FDA Commissioner Scott Gottlieb, M.D. announced that the agency had submitted its final work plan to Congress.
5/9/2017: The FDA Science Board held a meeting to review the proposal.
5/5/2017: The FDA released its plan outlining proposed uses of innovation funds.

20170707 07/07/2017 FDA, Funding, Regulatory Affairs
fa fa-2x fa-check Sec. 1004. Budgetary treatment. Provision in effect upon enactment. Further tracking not required.

Complete.

20161213 12/13/2016 FDA, Funding, NIH
fa fa-2x fa-long-arrow-right Sec. 2034. Reducing administrative burden for researchers. 12/13/2017: directs OMB to establish of the Research Policy Board.
12/13/2018: requires HHS review and revision of regulations and policies to reduce the administrative burden on researchers.
12/13/2018: requires HHS and USDA review and revision of regulations and policies for the care and use of laboratory animals to reduce administrative burden on researchers.
12/13/2018: requires submission of a Research Policy Board report to the White House and Congress containing formal recommendations on harmonization of policies to reduce administrative burden on researchers.
12/13/2020: requires publication of GAO report on the Research Policy Board's activities.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, GAO, HHS, NIH, Research
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.

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

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.

20171002 10/02/2017 CDC, FDA, Guidances, NIH, Regulatory Affairs, Reports, Research
fa fa-2x fa-long-arrow-right Sec. 2052. Compliance activities reports. 12/13/2018: requires issuance of a Report On Activities To Encourage Compliance describing education and outreach, guidance, enforcement, and other activities undertaken to encourage compliance with section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
Not later than 2 years after the final compliance date under the final rule implementing section 402(j) of the Public Health Service Act, and every 2 years thereafter for the next 4 years, issuance of a Report on Clinical Trials

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 Clinical Trials, FDA, NIH, Reports, Research
fa fa-2x fa-long-arrow-right Sec. 2054. Consultation. 3/13/2017 (90 days): requires HHS to consult with relevant Federal agencies, including the Food and Drug Administration, the Office of the National Coordinator for Health Information Technology, and the National Institutes of Health, as well as other stakeholders (including patients, researchers, physicians, industry representatives, and developers of health information technology) to receive recommendations with respect to enhancements to the clinical trial registry data bank under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)), including with respect to usability, functionality, and search capability.

6/1/2017: NLM rolled out the first in a series of changes to ClinicalTrials.gov
3/16/2017: in a letter responding to several organizations who expressed interest in ensuring the requirements of this provision be fulfilled, the Director of the NIH highlighted a new partnership between NIH and technical experts at 18F to make enhancements to ClinicalTrials.gov.
2/28/2017: the Secretary of HHS delegated the authority to fulfill the requirements of this Section to the NIH.
2/1/2017: a new beta version of ClinicalTrials.gov was released and is available here."

20170601 06/01/2017 Clinical Trials, Data Sharing, FDA, NIH, ONC, Research
fa fa-2x fa-long-arrow-right Sec. 2062. Tick-borne diseases. Requires HHS to establish the "Tick-Borne Disease Working Group." (And subsequent sun-setting of the working group 6 years after enactment of the act.)
12/13/2018 (and every 2 years thereafter): delivery of a summary of tick-born disease research, treatment, and epidemiological studies.

7/17/2017: HHS announced the establishment the Tick-Borne Disease Working Group and launched the group's website.

20170717 07/17/2017 CDC, FDA, HHS, NIH, 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. 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

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.

20170908 09/08/2017 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.

Complete.

20161213 12/13/2016 FDA, Patient Engagement
fa fa-2x fa-long-arrow-right Sec. 3004. Report on patient experience drug development. 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
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.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Guidances, Medical Product Development, Regulatory Affairs, Reports
fa fa-2x fa-binoculars Sec. 3012. Targeted drugs for rare diseases. Permits FDA to allow the sponsor of a drug or biologic application for a genetically targeted drug or variant protein targeted drug to rely on data for the same or similar technology from previously approved applications developed by the same sponsor.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Rare Disease, Regulatory Affairs
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.

FasterCures will periodically update based on the implementation and use of the voucher program.

20161213 12/13/2016 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.

Complete.

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.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 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. 3023. Protection of human research subjects. 12/13/2018: requires HHS to submit a report to Congress describing progress being made to harmonize differences between the human subject regulations under the Common Rule and the Federal Food Drug and Cosmetic Act.

12/13/2019: requires harmonization of these rules is to be completed.

9/25/2017: FDA issued guidance entitled, "Minutes of Institutional Review Board (IRB) Meetings - Guidance for Institutions and IRBs" consistent with the goal of rule harmonization set forth in this section of 21st Century Cures. Further context for this guidance was laid out in the Federal Register Notice

20170925 09/25/2017 Clinical Trials, FDA, Health Citizenship, HHS, NIH, Research
fa fa-2x fa-binoculars Sec. 3024. Informed consent waiver or alteration for clinical investigations. Gives FDA the flexibility to waive or alter informed consent requirements for clinical trials with minimal risk.

7/24/2017: FDA announced its intent to revise its informed consent regulations to add a waiver or alteration for minimal risk clinical investigations, under appropriate human subject protection safeguards, to the two existing exceptions from informed consent. FDA also issued guidance, informing sponsors, investigators, and IRBs on FDA's approach to such investigations in the interim until the final regulations are issued.

20170724 07/24/2017 Clinical Trials, FDA, Research
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.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 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. 3037. Health care economic information. Clarifies the scope of permissible manufacturer communications regarding health care economic information to certain entities.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA
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.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Guidances, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3041. Antimicrobial resistance monitoring. 12/13/2017, and annually thereafter: requires FDA and CDC to issue reports addressing national trends in antimicrobial use and resistance to those drugs.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 CDC, FDA, HHS, Infectious Disease, Reports
fa fa-2x fa-long-arrow-right Sec. 3042. Limited population pathway. Creates a new pathway for FDA to approve antibacterial and antifungal drugs based for limited populations, using a benefit-risk profile specific to that population.
6/13/2018: requires FDA to issue draft guidance describing this pathway and related processes.
At least every 2 years, FDA must report to Congress on the applications and approvals under this program.
12/31/2021: requires GAO issuance of a report on this program.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, GAO, Infectious Disease, Regulatory Affairs, Reports
fa fa-2x fa-check Sec. 3043. Prescribing authority. Clarifies that nothing in this section restricts the authority of healthcare providers to prescribe antimicrobial drugs or products. In effect upon enactment.
Complete. 20161213 12/13/2016 FDA, Infectious Disease
fa fa-2x fa-long-arrow-right Sec. 3044. Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devices. 12/13/2017: instructs FDA to establish and regularly maintain a website that lists appropriate interpretive criteria standards for antimicrobial drug susceptibility assays.
12/13/2018: requires FDA to submit a report to Congress on implementation of this provision.


FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Infectious Disease, Regulatory Affairs, Reports
fa fa-2x fa-long-arrow-right Sec. 3051. Breakthrough devices. 12/13/2017: requires FDA to issue guidance on the implementation of the medical device review pathway established by this provision.
1/1/2019: requires FDA to issue a report to Congress on the new medical device review pathway and opportunities for improvement.

10/25/2017: FDA announced the availability of draft guidance entitled “Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff.”

20171025 10/25/2017 FDA, Medical Devices, 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.

6/7/2017: 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.

20170607 06/07/2017 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.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Guidances, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3055. Classification panels. Requires FDA to provide an annual opportunity for stakeholders to provide recommendations for individuals with appropriate expertise to fill voting member positions on medical device classification panels

6/23/2017: FDA is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health.

20170623 06/23/2017 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-check Sec. 3056. Institutional review board flexibility. Removes the requirement that a sponsor of medical device trial use a local institutional review board. In effect upon enactment.

6/7/2017: On June 7, 2017 FDA rule notice in the Federal Register: “section 3056 of the 21st Century Cures Act amended section 520 of the FD&C Act to remove the requirement for institutional review committees, i.e., IRBs, for devices to be “local”, (amending 21 U.S.C. 360j, passim). This final rule amends 21 CFR 814.124(a), “IRB approval”, to remove the term “local” and related language in order to accurately reflect the requirements recently enacted into law.”

20170607 06/07/2017 FDA, 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.

Additional information on the Clinical Laboratory Improvement Amendments (CLIA) can be found on the CMS website.

20161213 12/13/2016 CMS, FDA, Guidances, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3058. Least burdensome device review. 6/13/2018: requires FDA to conduct an audit on training and use of least burdensome requirements during review of medical devices.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3059. Cleaning instructions and validation data requirement. 6/11/2017: requires HHS to identify and publish of a list of reusable medical devices that require additional instruction on, and validation of, proper cleaning and disinfection procedures.

6/9/2017: On June 9, 2017 FDA published such a list in the Federal Register. This list becomes effective on August 8, 201

20170609 06/09/2017 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3060. Clarifying medical software regulation. 12/13/2018 (and every two years thereafter): requires HHS issuance of a report on the current state of health-related software and the regulation of those products.

12/30/2016: FDA communicated its interpretation of this policy through final guidance titled "Medical Device Accessories--Describing Accessories and Classification Pathway for New Accessory Types"

20161213 12/13/2016 FDA, Health IT, Regulatory Affairs, Reports
fa fa-2x fa-long-arrow-right Sec. 3054. Certain class I and class II devices. 3/13/2017 (and every 5 years thereafter), instructs FDA to publish in the Federal Register a notice that contains Class II devices exempt from reporting requirements due to low risk; followed by 60 day public comment period. Final list published 7/11/2017.
4/12/2017 (and every 5 years thereafter): instructs FDA to provide a list of Class I devices exempt from reporting requirements due to low risk.

11/7/2017: FDA published an order to exempt autosomal recessive carrier screening gene mutation detection systems from the premarket notification requirements, subject to certain limitations. 

4/13/2017: FDA issued a notice in the Federal Register identifying a list of class I devices that are now exempt from premarket notification requirements, subjects to certain eliminations. FDA's action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation.

3/14/2017: FDA issued a notice in the Federal Register identifying more than 1,000 medical class II devices it is proposing to exempt or partially exempt from the premarket review process. A 60-day comment period is now open, after which FDA may narrow or expand this list.

20171107 11/07/2017 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service. 12/13/2020: requires GAO submission to Congress of a report on the effect of these amendments to HHS hiring authorities.

7/17/2017: FDA Commissioner Scott Gottlieb, M.D. announced a new hiring pilot, aimed at helping the agency fill hundreds of empty staff positions, including 500 just at its drug center.
5/25/2017: The hiring freeze of the administration was lifted from FDA.
3/10/2017: Read our memo, "Strengthening FDA’s Workforce: Opportunities for Action"
1/20/2017: Plans to reduce the size of the Federal workforce may adversely impact FDA.

20170717 07/17/2017 FDA, GAO, HHS, NIH, Reports, Workforce
fa fa-2x fa-long-arrow-right Sec. 3072. Hiring authority for scientific, technical, and professional personnel. 6/13/2018: requires FDA submission to Congress of a report on workforce needs and planning.
1/1/2022: requires GAO issuance of a report on FDA progress to recruit and retain staff.

7/17/2017: FDA Commissioner Scott Gottlieb, M.D. announced a new hiring pilot, aimed at helping the agency fill hundreds of empty staff positions, including 500 just at its drug center. 
5/25/2017: The hiring freeze of the administration was lifted from FDA.
3/10/2017: Read our memo, "Strengthening FDA’s Workforce: Opportunities for Action" 
1/20/2017: Plans to reduce the size of the Federal workforce may adversely impact FDA.

20170717 07/17/2017 FDA, GAO, Reports, Workforce
fa fa-2x fa-long-arrow-right Sec. 3073. Establishment of Food and Drug Administration Intercenter Institutes. 12/13/2017: requires FDA establishment of at least one Intercenter Institute.

On January 19, 2017, Commissioner Califf announced the formation of the Oncology Center of Excellence and named Richard Pazdur as its director.  The FDA allocated $3.6 million of existing agency funds to establish the OCE. However, a drafting error in sec. 1001(b)(3)(A) may prevent FDA from receiving an additional $75 million to fund the OCE. (Read more here and here).

20170119 01/19/2017 FDA, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3075. Drug surveillance. Makes targeted edits to FDA Drug Surveillance program to allow FDA to focus on risk.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA
fa fa-2x fa-binoculars Sec. 3076. Reagan-Udall Foundation for the Food and Drug Administration. Makes key updates to Reagan-Udall Foundation.

For more information on the Reagan-Udall Foundation. FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA
fa fa-2x fa-long-arrow-right Sec. 3086. Encouraging treatments for agents that present a national security threat. Establishes a Priority Review Voucher program at FDA to incentivize the development of medical countermeasures; sunsets 10/1/2023.


10/2/2017: Fee rate announced for using a material threat medical countermeasures priority review voucher for fiscal year (FY) 2018. 

4/28/2017: For more information on FDA Priority Voucher Programs please review this RAPS article entitled "Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers." As noted in the articled, to date no product has been awarded a priority review voucher under the medical counter measures program. For more information on FDA's Medical Countermeasures work relating to 21st Century Cures.

FasterCures will periodically assess this item as appropriate. For more information on FDA's Medical Countermeasures work relating to 21st Century Cures.

20171002 10/02/2017 FDA, Medical Countermeasures, Regulatory Affairs
fa fa-2x fa-check Sec. 3088. Clarifying Food and Drug Administration emergency use authorization. Clarifies Food and Drug Administration emergency use authorization.

Complete. For more information on FDA's Medical Countermeasures work relating to 21st Century Cures.

20161213 12/13/2016 FDA, Medical Countermeasures, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3093. Encouraging vaccine innovation. 12/13/2017: requires HHS to submit a report to Congress on promoting innovation in infectious disease vaccine development.

The National Vaccine Advisory Committee 2017 meeting on June 6 and June 7 with include an update on the the Secretary of the Department of Health and Human Services' report on vaccine innovation required by this section and other themes related to encouraging vaccine innovation. Information on the final meeting agenda will be posted prior to the meeting on the NVAC website.

20170417 04/17/2017 BARDA, CDC, FDA, HHS, Infectious Disease, NIH, Reports, Vaccines
fa fa-2x fa-check Sec. 3101. Technical corrections. Further tracking not required. In effect upon enactment.

Complete.

20161213 12/13/2016 FDA
fa fa-2x fa-check Sec. 3102. Completed studies. Strikes studies from the law that have been completed.

Complete.

20161213 12/13/2016 FDA

 

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