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.

The NCI Regulatory Affairs Liaison will first direct an investigator with an IND issue to the appropriate FDA guidance documents, regulations, or Web sites, or to the appropriate staff at FDA. The FDA staff will also be prepared to assist the clinical investigator with general questions regarding new medical products to treat cancer.

Significant issues not resolved through existing FDA procedures will be discussed by one of the IOTF subcommittees or referred to the Process Subcommittee's Senior Leadership Team.

Currently, the pilot program is limited to NCI-funded intramural and extramural investigators and investigators with approved Rapid Access to Intervention Development applications. "This joint NCI/FDA Program has been implemented so that barriers may be removed quickly and clinical studies can proceed in a timely manner," notes Dr. Christian. "It is hoped that this process will expedite the initiation of clinical studies and result in more rapid development of new agents."

For more information, go to the NCI Regulatory Affairs Liaison Web site at http://www.tech-res-intl.com/ncifdahelp/, or contact the service by phone (301-897-1705), e-mail (NCIFDAHELP@tech-res.com), or fax (301-897-1703). To initiate a request, investigators should provide their name, a summary of the nature of the IND regulatory issue, the name and number of their NCI-funded project, and the name and location of their institution. Investigators will be contacted by the NCI Regulatory Affairs Liaison if additional information is necessary.

By Bill Robinson