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Special protocol assessment final guidance

Executive Summary

FDA's 1special protocol assessment guidance, issued May 17, makes "minor changes" to the draft "to make the document more clear." The draft guidance was released in February 2000 (2"The Pink Sheet" Feb. 14, 2000, p. 18). The House Commerce/Oversight Subcommittee is examining special protocol assessments in connection with its investigation into ImClone's BLA for Erbitux (3"The Pink Sheet" March 25, p. 20)...

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