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 http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm 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
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