Oncology Has Different Risk Management Standards, FDA’s Pazdur Acknowledges
By
Mary Jo Laffler / Email the Author / “The Pink Sheet” Jun. 13, 2011, Vol. 73, No. 24
Regulatory Update / Word Count: 1139 / Article # 00110613008
Executive Summary
Risk mitigation in the oncology setting is unique, largely because of the different benefit/risk ratio, but also because the therapeutic area has "a de facto restricted distribution system," as FDA Office of Oncology Drug Products Director Richard Pazdur put it.
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