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U.S. Department of Health and Human Services

For Consumers

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Cancer Specific Resources

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Accelerated Approval

The committee discussed accelerated approval of drugs to treat cancer. The meeting was intended to 1) Review the status of phase IV clinical studies; (2) identify difficulties and (3) provide advice to sponsors to assist in the planning and execution of postmarketing commitments of newly approved drugs associated with completion of phase IV commitments.

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March 8, 2005 Oncologic Drugs Advisory Committee Meeting

The committee discussed accelerated approval of drugs to treat cancer. The meeting was intended to 1) Review the status of phase IV clinical studies; (2) identify difficulties and (3) provide advice to sponsors to assist in the planning and execution of postmarketing commitments of newly approved drugs associated with completion of phase IV commitments.

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June 7/8, 2001 Oncologic Drugs Advisory Committee Meeting

The committee discussed single patient use of non-approved oncology drugs and biologics

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