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The 21st Century Cures Act is a United States law enacted by the 114th United States Congress in December 2016 and then signed into law on December 13, 2016. It authorized $6.3 billion in funding, mostly for the National Institutes of Health . [ 1 ]
In January 2018, the Health Information Technology Advisory Committee (HITAC) was established as required under the 21st Century Cures Act. Health Information Technology Advisory Committee (HITAC) | HealthIT.gov. Term: 2021-current Co-Chair: Aaron Miri Co-Chair: Denise Webb Term: 2018-2020 Co-Chair: Robert Wah Co-Chair: Carolyn Peterson
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...
The 21st Century Cures Act, passed in 2016, prohibited information blocking, which had slowed interoperability. [2] In 2018, the Trump administration announced the MyHealthEData initiative to further allow for patients to receive their health records. [ 3 ]
Supplemental needs trust is a US-specific term for a type of special needs trust (an internationally recognized term). [1] Supplemental needs trusts are compliant with provisions of US state and federal law and are designed to provide benefits to, and protect the assets of, individuals with physical, psychiatric, or intellectual disabilities, and still allow such persons to be qualified for ...
The 21st Century Cures Act enacted by the 114th United States Congress in December 2016 allows researchers to waive the requirement for informed consent when clinical testing "poses no more than minimal risk" and "includes appropriate safeguards to protect the rights, safety, and welfare of the human subject." [17]
The 21st Century Cures Act which addressed fast-tracking approval of specialty pharmaceuticals was particularly beneficial for dealing with the development of 2nd run biologics (which might be more easily understood as "generic biologics", though they do not exist). [71] Debate around the act raised some important questions about the efficacy ...
Regenerative Medicine Advanced Therapy (RMAT) is a designation given by the Food and Drug Administration to drug candidates intended to treat serious or life-threatening conditions under the 21st Century Cures Act. [1] A RMAT designation allows for accelerated approval based surrogate or intermediate endpoints. [2]