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AACR applauds FDA decision to create new office of oncology drug products

By creating a new Office of Oncology Drug Products (OODP), the U.S. Food and Drug Administration has taken a significant step toward speeding the delivery of new drugs for the treatment and prevention of cancer, according to the American Association for Cancer Research (AACR).

"We applaud this great news," said Margaret Foti, Ph.D., M.D. (h.c.), chief executive officer of AACR, the world's oldest and largest scientific organization dedicated to cancer research. "Creating an office to make the review of oncologic products more efficient will accelerate approval of new drugs for treatment and prevention, all of which will benefit the cancer patient."

As envisioned, the new office to be located in the FDA's Center for Drug Evaluation and Research (CDER) will streamline the review of applications for oncology drugs and biologics, thereby speeding the development of new therapies.

To support this new office and coordinate work performed throughout the FDA Centers related to the prevention, diagnosis, and treatment of cancer, the FDA is also creating an Oncology Program that will assist cross-agency expert consultation, provide a forum to discuss and develop regulatory policy and standards, and serve as a focal point for agency interaction and collaboration with the cancer community.

This positive development stems, in part, from the growing relationship between the FDA and the National Cancer Institute under an interagency agreement approved last year to enhance clinical research and the scientific evaluation of new cancer medications and diagnostics.

"The AACR feels confident that this office will increase the clarity, consistency, and predictability of the clinical development pathway so that products could be brought to the patient in the most efficient manner," said Foti.


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Contact: Warren R. Froelich
froelich@aacr.org
215-440-9300
American Association for Cancer Research
16-Jul-2004


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