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Previous Volume 329:1169-1173 October 14, 1993 Number 16 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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Scientific advances in the past decade have made the clinical testing of somatic-cell therapy and gene therapy a reality. Early trials in humans suggest that important new diagnostic and therapeutic tools are on the horizon. The objectives of this article are to examine the regulation of somatic-cell and gene therapy by the Food and Drug Administration (FDA) in the context of the agency's traditional role in the development of biologic products and to stimulate discussion in areas in which policy is still being formulated.

The technology of somatic-cell and gene therapy has moved from the bench to clinical evaluation with . . . [Full Text of this Article]

Somatic-Cell Therapy

Gene Therapy

Clinical Development of Biologic Products

The Approach to Regulation

The Investigational Phase

The Product License

An Interactive Process

A Prudent Approach

Source Information

From the Office of the Commissioner (D.A.K., K.L.F.), and the Center for Biologics Evaluation and Research (J.P.S., P.D.N., K.C.Z., J.W.), Food and Drug Administration, Rockville, Md.

Address reprint requests to Dr. Woodcock at HFM-500, Woodmont Office Complex, Suite 400 S., 1401 Rockville Pike, Rockville, MD 20852-1448.

References

This article has been cited by other articles:

• Halme, D. G., Kessler, D. A. (2006). FDA Regulation of Stem-Cell-Based Therapies. NEJM 355: 1730-1735 [Full Text]