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Regulatory Approval not required for retrospective analysis of Inotuzumab ozogamicin: CDSCO panel Tells Pfizer
New Delhi: In response to the drug major Pfizer's proposal to conduct the retrospective and non-interventional study of the anticancer drug Inotuzumab Ozagamicin, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined that this study does not require regulatory approval as the study is for retrospective evaluation of data...
New Delhi: In response to the drug major Pfizer's proposal to conduct the retrospective and non-interventional study of the anticancer drug Inotuzumab Ozagamicin, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined that this study does not require regulatory approval as the study is for retrospective evaluation of data from medical records of patients who have already been treated with the drug and recommended.