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www.fdanews.com/articles/68951-nci-fda-announce-research-and-regulatory-review-fellowship-program

NCI, FDA Announce Research and Regulatory Review Fellowship Program

February 18, 2005

In preparation for the new generation of molecular-based oncology medical products, the

NIH's National Cancer Institute (NCI) and the FDA have announced an NCI-FDA Research and Regulatory Review Fellowship program.

"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 Lester Crawford. "This cross-fertilization of the FDA and the 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 the FDA's offices and laboratories in the Washington, D.C., area, and will be exposed to the regulatory requirements that must be built into the early stages of medical product development.