News Release

NCI and FDA Announce Research and Regulatory Review Fellowship Program

In preparation for the new generation of molecular-based oncology medical products, the National Cancer Institute (NCI), part of the National Institutes of Health, and the Food & Drug Administration (FDA) announced today an NCI-FDA Research and Regulatory Review Fellowship program.

"NCI and FDA share the common goal of bringing safe and effective products to cancer patients," said NCI Director Andrew von Eschenbach, M.D. "Collaboration among the individuals and institutions involved in the discovery, development and delivery of medical products is critical to achieve our goal of eliminating the suffering and death due to cancer."

"As new therapies are developed using the latest breakthroughs, fast progress requires that researchers understand the safety and effectiveness questions that regulators must ask, and that reviewers understand the critical details of the latest science," said Acting FDA Commissioner Dr. Lester M. Crawford. "This cross-fertilization of FDA and NCI will be invaluable in helping move the next wave of promising cancer-fighting agents through the development pipeline."

The program is designed to train a cadre of researchers to bridge the processes from scientific discovery through clinical development and regulatory review of new oncology products. Fellows will work and train primarily at FDA's offices and laboratories in the Metropolitan Washington, D.C., area, and will be exposed to the regulatory requirements that must be built into the early stages of medical product development.

The NCI-FDA Research and Regulatory Review Fellowships offer an unprecedented career opportunity for participating researchers to become uniquely positioned to facilitate the new age of molecular medicine.

The new generation of targeted therapies and diagnostic products will demand new skills and processes that must be incorporated into the current research and regulatory system. The NCI-FDA fellowship program represents an innovative and collaborative approach to that objective.

The NCI-FDA Research and Regulatory Fellowship program is an initiative of NCI's and FDA's Interagency Oncology Task Force (IOTF), a major collaboration between the two agencies. The IOTF was established in recognition of the fact that cross-fertilization between the NCI and FDA is critical for developing the knowledge base necessary to bring new, molecular-based therapies and diagnostics into the clinical practice of oncology.

The fellowships are also viewed by the two federal health agencies as a pilot program and possible model for "training programs of the future"
for other diseases beyond cancer. The key goal of the program, over the next three to five years, is to grow a uniquely trained workforce to foster a new generation of therapies.

The NCI-FDA Research and Regulatory Review Fellowships will consist of four different programs, each with its own curriculum:

• Program One-Clinical Oncology Product Research/Review for Oncology Fellows. Designed for M.D.s or M.D./Ph.D.s.
• Program Two-Clinical Oncology Product Research/Review for Board-Certified Oncologists.
• Program Three-Oncology Product Research/Review Fellows. Designed for M.D.s, Ph.D.s or M.D./Ph.D.s.
• Program Four-Cancer Prevention Fellows. Designed for M.D.s, Ph.D.s or scientists with equivalent doctoral degrees.

For more information about the NCI-FDA Research and Regulatory Review Fellowship program, please go to http://iotftraining.nci.nih.gov.

For additional information about the National Cancer Institute, please visit http://www.cancer.gov.

For information about the Food and Drug Administration, please go to http://www.fda.gov.

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