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Cancer prevention drugs require protocol assessment before Phase III--FDA.

All oncologic risk reduction drugs should have a special protocol assessment (SPA) before entering Phase III trials, FDA advises staff in a recently issued "Manual of Policies and Procedures" guidance, The Pink Sheet reports.

Drug sponsors "should be encouraged to submit an SPA for Phase III prevention studies, even when the trial is used to open a new IND," the MaPP states.

The MaPP, entitled "Clinical Review of Drugs to Reduce the Risk of Cancer," outlines the review policies for cancer prevention agents to be followed by FDA's Office of Oncologic Drug Products.

Established as part of the recent reorganization of the CDER's Office of New Drugs, OODP officially began operations this past summer under the leadership of Director Richard Pazdur.

Prior to the establishment of OODP, FDA transferred regulatory oversight for most non-biologic cancer prevention applications from various CDER review divisions to the Division of Oncology Drug Products, which now is a component of the new cancer office.

Two approved products--Pfizer's Celebrex and Axcan's Photofrin--and 69 investigational new drugs have been transferred to the division.

Noting that the 30-day review "may not permit sufficient time to evaluate a complex Phase III prevention study submitted as a new IND," the MaPP instructs reviewers to "encourage sponsors to schedule pre-IND application/end-of-Phase II meetings before submitting the IND."

If the safety review of a Phase III study submitted as part of an IND requires consultation with a specific subject matter review division or other office or center, sponsors should be informed that such discussions will necessitate the "full 45-day review clock of an SPA," the MaPP states.
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Title Annotation:Regulatory Update
Publication:Pharmaceutical Processing
Date:Jan 1, 2006
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