Abstract
Unapproved investigational drugs have substantial uncertainty in terms of efficacy and safety. The compassionate use of investigational drugs, nevertheless, provides a patient with a serious disease or life-threatening condition a pathway to access unauthorized medications. This has gained significant traction during the Coronavirus 2019 disease pandemic. We review the laws and regulations of programs in the United States of America, Australia, the United Kingdom, and South Korea, where such programs are currently in effect, specifically on the following aspects: regulations, requirements, eligible patients, charges, and patient safety plans. Additionally, we investigated therapeutic-approval cases in South Korea from January 2016 to March 2021.
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