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KMID : 0370220210650060441
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Yakhak Hoeji
2021 Volume.65 No. 6 p.441 ~ p.452
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Regulations and Guidelines for Therapeutic Approval of Investigational Drugs
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Park Na-Young
Min Sa-Rim
Shon Young-Hu
Nam Jin-Hyun
Kwon Sun-Hong
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Abstract
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Unapproved investigational drugs have substantial uncertainty in terms of efficacy and safety. The compassionateuse of investigational drugs, nevertheless, provides a patient with a serious disease or life-threatening condition a pathwayto access unauthorized medications. This has gained significant traction during the Coronavirus 2019 disease pandemic. Wereview the laws and regulations of programs in the United States of America, Australia, the United Kingdom, and SouthKorea, where such programs are currently in effect, specifically on the following aspects: regulations, requirements, eligiblepatients, charges, and patient safety plans. Additionally, we investigated therapeutic-approval cases in South Korea fromJanuary 2016 to March 2021.
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KEYWORD
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Investigational drug, Therapeutic use, Compassionate use, Health policy, Expanded access
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