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Omission of bridging study data clarified
The Korea Food and Drug Administration Thursday unveiled its additional guideline to waive the bridging study data on chronic myeloid leukemia and multiple myeloma.
Under the guideline, a drug manufacturer will not be obliged to submit any bridging study in patients with Philadelphia-positive in chronic myeloid leukemia and multiple myeloma, who fail to respond to the second treatment.
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Under the guideline, a drug manufacturer will not be obliged to submit any bridging study in patients with Philadelphia-positive in chronic myeloid leukemia and multiple myeloma, who fail to respond to the second treatment.
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약업닷컴의 모든 컨텐츠는 저작권법의 보호를 받습니다. 무단 전재⋅복사⋅배포 등을 금합니다.