Increasing Use of Compassionate Use/Managed Access Channels to Obtain Medicines for Use in COVID-19.

CLINICAL PHARMACOLOGY & THERAPEUTICS(2020)

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摘要
The coronavirus disease 2019 (COVID-19) pandemic has triggered an extensive need for new therapeutics and there has been widespread use of unapproved/repurposed medicines. Several countries have regulations for access to unapproved medicines, known as compassionate use, managed/expanded access or emergency use. The Novartis Managed Access activity for COVID-19 delivered unapproved/repurposed medicines to nearly 6,000 patients over a 6-month period. With the rapid growth of such access mechanisms to address COVID-19, a better understanding of these channels is required.
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关键词
COVID-19,Compassionate use,Emergency use,Expanded access,Global health response,Managed Access,Pre-approval access,Repurposed therapies
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