Managing the Obstacles in the Path to Regulatory Approval of PET

  • James F. Lamb

Abstract

At a 1988 symposium at the University of California Lawrence Berkeley Laboratory on local and regional delivery systems for PET1, Dr. John Palmer, then Director of the FDA Division of Medical Imaging, Surgical and Dental Products, was called to task during a question and answer period for FDA’s apparent lack of responsiveness in approving the radiopharmaceutical 2-18FDG for use in PET. He patiently explained that the FDA Center for Drug Evaluation and Research, of which his group is a part, does not seek out experimental products to evaluate. It reviews applications submitted to it by outside sponsors. He said that what he was trying to figure out was that if PET is so allfired important, why, in the twelve years or so FDG has been around, no one has submitted an NDA for it.

Keywords

Good Manufacture Practice Positron Emission Tomographic Lawrence Berkeley Laboratory Health Care Financing Administration Current Good Manufacture Practice 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 1.
    J.F. Palmer, Symposium on Local and Regional Delivery Systems for PET, 1988.Google Scholar
  2. 2.
    Minutes of the FDA Radiopharmaceutical Advisory Committee, Center for Drug Evaluation and Research, FDA, 1989Google Scholar
  3. 3.
    T. Ido, C.N. Wan, V. Casella, et. al., J. Labelled Compd. Radiopharm. 14, 175 (1978).CrossRefGoogle Scholar
  4. 4.
    H.N. Wagner, J.Nucl. Med. 32, 561 (1991).PubMedGoogle Scholar
  5. 5.
    FDA Public Hearing: Regulatory Approach to Positron Emission Tomographic (PET) Radiopharmaceuticals, March 5, 1993.Google Scholar

Copyright information

© Springer Science+Business Media New York 1995

Authors and Affiliations

  • James F. Lamb
    • 1
  1. 1.CTI Services, IncKnoxvilleUSA

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