| 2016 |
21st Century Cures Act |
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Continued to build on previous legislation to incorporate patient perspectives into drug and device development, and to modernize clinical trials design through use of real-world evidence and clinical outcomes assessments.
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Provided for recruitment and retention of appropriate experts, and established 2 new expedited product development programs: 1) RMAT; and 2) breakthrough devices.
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Directed the FDA to create intercenter institutes to coordinate activities in major disease areas between the centers for drug, biologics and device centers, and to improve the regulation of combination products.
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| 2017 |
FDARA of 2017 |
In addition to miscellaneous systems reporting and organizational improvements:
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Continued the 5-yr reauthorization cycle of human medical product user fees (PDUFA VI—see following text), and allows the FDA to use the revenue to support the marketing applications for brand-name and generic drugs, biological, and biosimilar products, and medical devices
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Established the renewed fees related to drugs, devices, generic drugs, and biosimilars (PDUFA)
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Reauthorized existing programs such as the Orphan Drug Program
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Included the RACE for Children Act, requiring evaluation for new molecular targets and biologics intended for adults that are specifically targeted for cancers in children, elimination of orphan exemption from pediatric studies
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Established rules for device inspections, established means to improve access to generic drugs, and included provisions for FDA performance reporting, as well as other administrative enhancements
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| 2017 |
PDUFA VI (a section of the FDARA) |
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Renewed drug development user fees
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Provided for system enhancements, such as improvement of the electronic submissions system
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Required the FDA to work toward incorporating adaptive, Bayesian, and other complex trial designs and explore use of real-world evidence in approval processes
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Required the FDA to work on defining biomarkers, trial endpoints, and other drug development tools
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Required the FDA to provide means to incorporate patient and care provider perspectives into clinical trial designs
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Provided for enhanced financial and staffing transparency
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