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CALIFORNIA LAW REVISION COMMISSIONSTAFF MEMORANDUMStudy G301September 2, 2016Memorandum 201646
Government Interruption of Communication Service
(Draft Recommendation)
In 2013, the Legislature enacted
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What is expanding access to high-impact?
Expanding access to high-impact refers to initiatives aimed at increasing the availability and accessibility of high-impact interventions, therapies, or technologies to broader populations, especially those who are underserved.
Who is required to file expanding access to high-impact?
Typically, sponsors of clinical trials or manufacturers of therapeutic products that seek to provide expanded access must file relevant documentation, including Institutional Review Boards (IRB) or ethics committee approvals.
How to fill out expanding access to high-impact?
To fill out expanding access to high-impact, sponsors should provide detailed information about the product, the target patient population, the rationale for expanded access, and the proposed treatment protocol.
What is the purpose of expanding access to high-impact?
The purpose is to provide patients with serious or life-threatening conditions access to investigational therapies that have shown promise in clinical trials, but are not yet widely available.
What information must be reported on expanding access to high-impact?
Reported information should include patient demographics, the nature of the condition being treated, treatment outcomes, and any adverse events that occur during the expanded access treatment.
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