NCI Cancer Bulletin: A Trusted Source for Cancer Research NewsNCI Cancer Bulletin: A Trusted Source for Cancer Research News
November 29, 2005 • Volume 2 / Number 46 E-Mail This Document  |  Download PDF  |  Bulletin Archive/Search  |  Subscribe

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Featured Article

NCI Service Assists Researchers with Investigational Drug Issues

NCI-funded investigators can now turn to NCI for help with regulatory process issues as part of an effort to eliminate obstacles to the rapid development of promising new anticancer agents: Researchers can call the new NCI Regulatory Affairs Liaison.

NCI established the liaison position as a pilot program in cooperation with the Food and Drug Administration (FDA), under the NCI-FDA Interagency Oncology Task Force (IOTF). The primary purpose is to help applicants involved in the FDA's Investigational New Drug (IND) application process. IND is the FDA designation for a compound that has been submitted to FDA, has undergone a formal review process, and has been deemed appropriate for clinical testing in humans for specific indications. (Go to for more information.)

"Many IND application issues arise because of the complexity of the development process, the complexity of the FDA regulatory system, and a limited understanding on the part of investigators of the structure and procedures that may already exist within FDA to help resolve their problems," says Dr. Michaele Christian, NCI's co-chair of the IOTF Process Subcommittee, which developed the pilot program. However, she adds, some IND issues represent substantive scientific, medical, and regulatory disagreements that require innovative solutions.  Read more  

Director's Update

Guest Update by Dr. Mark Clanton

Looking Back at Katrina

Among the sad overabundance of images and news stories that emerged in the wake of Hurricane Katrina, particularly those from my hometown of New Orleans, I'd like to single out one that spoke volumes about this tragedy. It was a plea posted on a Katrina message board established by the American Society of Clinical Oncology (ASCO). The title: "Please help my mom." A daughter was searching for her mother's oncologist. "She has carcinoid cancer," the message read, "and I am very worried."

The cancer community came together quickly to respond to the needs of cancer patients, community oncologists, researchers, and many others affected by Katrina. As the NCI deputy in charge of coordinating NCI's response, I am very proud of our efforts during this disaster. It was especially gratifying to be part of a community-wide response, as NCI staff worked with many organizations and federal, state, and local health agencies to offer relief.  Read more  

The NCI Cancer Bulletin is produced by the National Cancer Institute (NCI). NCI, which was established in 1937, leads the national effort to eliminate the suffering and death due to cancer. Through basic, clinical, and population-based biomedical research and training, NCI conducts and supports research that will lead to a future in which we can identify the environmental and genetic causes of cancer, prevent cancer before it starts, identify cancers that do develop at the earliest stage, eliminate cancers through innovative treatment interventions, and biologically control those cancers that we cannot eliminate so they become manageable, chronic diseases.

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