Molecular Imaging News
March 4, 2005
Joint NCI-FDA Fellowship Program Announced
National Cancer Institute
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 and Drug Administration (FDA) announced on February 16 the creation of an NCI-FDA Research and Regulatory Review Fellowship program. The program, initiated by the joint Interagency Oncology Task Force, 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, DC, area and will learn first-hand about the regulatory requirements that must be built into the early stages of medical product development. "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 fellowships are viewed as part of a pilot program and as a possible model for future training programs. The NCI-FDA Research and Regulatory Review Fellowships will consist of 4 different programs, each with its own curriculum: (1) Clinical Oncology Product Research/Review for Oncology Fellows (designed for MDs or MD/PhDs); (2) Clinical Oncology Product Research/Review for Board-Certified Oncologists; (3) Oncology Product Research/Review Fellows (designed for MDs, PhDs or MD/PhDs; and (4) Cancer Prevention Fellows (designed for MDs, PhDs, or scientists with equivalent doctoral degrees).
For more information about the NCI-FDA Research and Regulatory Review Fellowship program, see http://iotftraining.nci.nih.gov.