[Skip navigation] FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Drug Evaluation and Research
  HHS Logo links to Department of Health and Human Services website

FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER

horizonal rule
CDER Home About CDER Drug Information Regulatory Guidance CDER Calendar Specific Audiences CDER Archives
Powered by Google

Medical Imaging and Drug Development

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.

FDA Critical Path Initiative

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.

  • "Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products" (March 2004)
  • Critical Path Web Page
  • Presentations from the FDA/DIA/BIO Meeting: Use of Medical Imaging as a Drug Development Tool, May 5-6, 2005
    • Regulatory Opportunities and Challenges of Imaging as a Drug Development Tool [PPT], George Mills, M.D., FDA
    • Criteria and Considerations: Imaging Data Submissions for BLA or NDA [PPT], George Mills, M.D., FDA
    • Biomarker Imaging in Drug Development & Licensed Products [PPT], George Mills, M.D., FDA
    • The Role of Radiography in Assessing Efficacy in Clinical Trials of Rheumatoid Arthritis [PPT], Jeffrey N. Siegel, M.D., FDA
    • The Critical Path Initiative: One Year Later [PPT] Janet Woodcock, M.D., FDA

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.

Related Guidances

  • Draft Guidance: Exploratory IND Studies [HTML] or [PDF]
  • Final Guidance: Developing Medical Imaging Drug and Biological Products
    • Part 1: Conducting Safety Assessments[PDF] (6/17/2004)
    • Part 2: Clinical Indications [HTML] or [PDF] (6/17/2004)
    • Part 3: Design, Analysis, and Interpretation of Clinical Studies PDF] (6/17/2004)

Related Sites

Back to Top     Back to Regulatory Info

Date created: June 6, 2005

horizonal rule