ASTRO encouraged by creation of FDA cancer office The FDA (Rockville, Md) is making significant changes to its organizational structure with the development of its Office of Oncology Drug Products (ODP), which will provide a stronger, more consistent approach to the review processes for drugs and therapeutic biologics used to prevent, diagnose, and treat cancer.
The American Society for Therapeutic Radiology and Oncology (ASTRO of Fairfax, Va) has announced that it fully supports the government's program and its attempt to speed the approval process for devices and drugs that relate to cancer. According to ASTRO, the ODP will give physicians a central location to seek information rather than having to contact numerous divisions within the FDA to receive answers for a subset of questions.
The ODP, which will be housed in the Center for Drug Evaluation and Research, is the first step toward improving the consistency of review and policy related to oncology drugs and will bring together a critical mass of oncologists who will help develop new therapies. Before the creation of the ODP, users had to contact the FDA's Center for Devices and Radiological Health (CDRH) to obtain information on devices. The user then had to contact another office to receive administration information in order to obtain additional details regarding the drug. The FDA developed the ODP to eliminate the time-consuming avenues that physicians and cancer advocacy organizations pursue while seeking answers.
Within the ODP, the FDA also is establishing a new oncology program to facilitate cross-agency expert consultation, particularly with the CDRH. The oncology program will provide a forum to discuss and develop regulatory policy and standards as well as serve as a focal point for agency interaction and collaboration with oncology professional societies, the National Cancer Institute, and other important stakeholders. This program also will coordinate cross-cutting training and oncology educational activities.
"ASTRO is pleased [about] the establishment of this new office and its cross-cutting communication program, and we are ready to lend our support in any way possible," said ASTRO Chair Joel E. Tepper, MD. "This is a step in the right direction in helping to ensure that millions of cancer patients have access to the best and safest treatments available."
ASTRO also is showing its support to the cancer communities by partnering with CURE Childhood Cancer (Atlanta) to raise awareness of cancer survivorship. This nonprofit organization is dedicated to conquering childhood cancer through research, education, and support of patients and their families.
CURE is working with ASTRO by participating in the Survivor Circle exhibit at the society's 46th Annual Meeting early this month in Atlanta. Created to recognize those who are battling cancer, the Survivor Circle focuses on the programs offered by local organizations to help patients and their families cope with their treatments. Visit www.curechildhoodcancer.org for more information.
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