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FDA Refuse-To-File Policy Records Requested Under House ImClone Probe

Executive Summary

The House Commerce/Oversight Subcommittee is asking FDA to provide records relating to its policy on refuse-to-file letters, as part of its broadening investigation into ImClone

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Special protocol assessment final guidance

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 The draft guidance was released in February 2000 (2"The Pink Sheet" Feb. 14, 2000, p. 18).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)...

Special protocol assessment final guidance

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 The draft guidance was released in February 2000 (2"The Pink Sheet" Feb. 14, 2000, p. 18).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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Hearings stemming from the House Energy & Commerce investigation of ImClone and its BLA for Erbitux are not likely to happen this year, Health Subcommittee Chairman Michael Bilirakis (R-Fl.) told reporters April 16. Committee Chairman Billy Tauzin (R-La.) added: "Staff has been meeting with FDA and stakeholders, but there has been no decision made as of yet." The House investigation is focusing on ImClone's representations to shareholders regarding the oncologic product and may include FDA review policies (1"The Pink Sheet" March 25, p. 20)...

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