Imaging technologies provide powerful insights into the distribution, binding, and other biological effects of pharmaceuticals. As part of its Critical Path initiative, FDA has joined the National Cancer Institute (NCI), the pharmaceutical industry, and academia in a number of activities that will facilitate the development of new imaging agents and the use of medical imaging during product development. We believe that with a little effort on the part of all of us, imaging agents and technologies can contribute important biomarkers and surrogate endpoints during disease progression and contribute to the development of new therapies to treat disease.
On March 16, 2004, FDA released a report addressing the recent slowdown in innovative medical therapies submitted to the FDA for approval, "Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products." The report describes the urgent need to modernize the medical product development process, the Critical Path, to make product development more predictable and less costly.
National Cancer Institute (NCI)-FDA Interagency Oncology Task Force Initiative (IOTF)
Under an agreement between FDA and the National Cancer Institute (NCI), the two agencies will share knowledge and resources to facilitate the development of new cancer drugs and speed their delivery to patients.
- Draft Guidance: Exploratory IND Studies
- Final Guidance: Developing Medical Imaging Drug and Biological Products