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  • MFDS reviews EUA of COVID-19 prevention drug Evusheld
  • by Lee, Hye-Kyung | translator Alice Kang | Jun 14, 2022 06:04am
MFDS conducts review on feasibility of Evusheld¡¯s clinical data and quality test data for EUA
The emergency use authorization review for AstraZeneca¡¯s COVID-19 preventive antibody therapy ¡®Evusheld¡¯ has begun in Korea.

The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) announced on the 10th that the ministry has started reviewing the emergency use authorization of Evusheld per request by the Korea Disease Control and Prevention Agency.

The MFDS will make a decision after reviewing the clinical trial and quality data that were submitted, followed by an expert advisory meeting and deliberation by the Public Health Emergency Response Medical Device Safety Management and Supply Committee.

Evusheld is an antibody treatment that is directly administered to immunocompromised patients(blood canc
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