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Rules concerning approval of protocol eased
The Korea Food and Drug Administration (KFDA) announced the revised rules concerning the approval of protocol of clinical drugs. The KFDA further notes:
1) The application to obtain the approval for a protocol may be made available through submission of summary data pertaining to safety and efficacy of drug.
2) The handling period of clinical trials will be shortened to 30 days due to ab...
1) The application to obtain the approval for a protocol may be made available through submission of summary data pertaining to safety and efficacy of drug.
2) The handling period of clinical trials will be shortened to 30 days due to ab...
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약업닷컴의 모든 컨텐츠는 저작권법의 보호를 받습니다. 무단 전재⋅복사⋅배포 등을 금합니다.