 |
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- Draft Guidance: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 |
|
