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Sec. 3011. Qualification of drug development tools.
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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12/13/2019: directs FDA to issue draft guidance on this qualification process.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.
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12/12/2018: The FDA announced a draft guidance on considerations to address when developing a biomarker, entitled "Biomarker Qualification: Evidentiary Framework."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.
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20181212 12/12/2018
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FDA,
Guidances,
Medical Product Development,
Regulatory Affairs,
Reports
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Sec. 3013. Reauthorization of program to encourage treatments for rare pediatric diseases.
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Reauthorizes the pediatric rare disease priority review voucher program until 2020.
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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"
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20171207 12/07/2017
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FDA,
Medical Product Development,
Rare Disease,
Regulatory Affairs
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Sec. 3014. GAO study of priority review voucher programs.
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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.
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FasterCures will periodically assess this item as appropriate.
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20161213 12/13/2016
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FDA,
GAO,
Medical Countermeasures,
Medical Product Development,
Rare Disease,
Regulatory Affairs
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Sec. 3016. Grants for studying continuous drug manufacturing.
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Allows the FDA to issue grants to further the study of continuous manufacturing for drugs.
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Complete.
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20161213 12/13/2016
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FDA,
Funding,
Medical Product Development
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Sec. 3021. Novel clinical trial designs.
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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.
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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.
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20180930 09/30/2018
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Clinical Trials,
FDA,
Guidances,
Medical Product Development,
Regulatory Affairs
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Sec. 3084. Medical countermeasures innovation.
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12/13/2020: requires GAO publication of a review of medical countermeasure innovation program established by this provision. The program will sunset on 9/30/2022.
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FasterCures will periodically assess this item as appropriate.
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20161213 12/13/2016
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BARDA,
GAO,
HHS,
Medical Countermeasures,
Medical Product Development,
Reports
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Sec. 3022. Real world evidence.
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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.
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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.
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20190510 05/10/2019
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FDA,
Guidances,
Medical Product Development,
Regulatory Affairs
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