Public Law 114-255

E696513

Public Law 114-255 is a major U.S. federal statute enacted in 2016 that accelerates medical product development, funds biomedical research initiatives like the Cancer Moonshot and the Precision Medicine Initiative, and reforms mental health and substance use disorder programs.

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Public Law 114-255 canonical 1

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Statements (49)

Predicate Object
instanceOf Act of Congress
United States federal statute
amends Federal Food, Drug, and Cosmetic Act NERFINISHED
Public Health Service Act NERFINISHED
Social Security Act NERFINISHED
authorizesAppropriationsFor Food and Drug Administration NERFINISHED
National Institutes of Health NERFINISHED
containsTitle Title III—Delivery NERFINISHED
Title II—Development
Title IV—Mental Health and Substance Use Disorder Provisions
Title I—Discovery
Title V—Savings Provisions
country United States of America
dateEnacted 2016-12-13
dateSigned 2016-12-13
enactedBy 114th United States Congress NERFINISHED
fundsProgram BRAIN Initiative NERFINISHED
Cancer Moonshot NERFINISHED
Precision Medicine Initiative NERFINISHED
hasSection provisions on breakthrough devices
provisions on compassionate use and expanded access
provisions on confidentiality and privacy of research data
provisions on real-world evidence in regulatory decision-making
hasTitle 21st Century Cures Act NERFINISHED
includesProvision coordination of federal mental health programs
data sharing and interoperability incentives
expedited review pathways for drugs and devices
mental health parity enforcement measures
opioid use disorder treatment reforms
patient-focused drug development measures
strengthening of community mental health services
support for regenerative medicine
jurisdiction United States of America
surface form: United States
legislativeSession 114th United States Congress NERFINISHED
primaryPurpose accelerate medical product development
address substance use disorders
modernize and streamline clinical trial processes
reform mental health programs
support biomedical research
publicLawNumber P.L. 114-255 NERFINISHED
shortTitle 21st Century Cures Act NERFINISHED
signedBy Barack Obama NERFINISHED
statutesAtLargeCitation 130 Stat. 1033
subjectArea biomedical research
drug regulation
health law
medical device regulation
mental health policy
substance use disorder treatment

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Referenced by (1)

Full triples — surface form annotated when it differs from this entity's canonical label.

21st Century Cures Act publicLawNumber Public Law 114-255