Current state of U.S. Food and Drug Administration regulation for cellular and gene therapy products: potential cures on the horizon

Cytotherapy ◽  
2019 ◽  
Vol 21 (7) ◽  
pp. 699-724 ◽  
Author(s):  
Michael Mendicino ◽  
Yong Fan ◽  
Deborah Griffin ◽  
Kurt C. Gunter ◽  
Karen Nichols
Keyword(s):  
Gene Therapy ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Current State

The FDA's Proposal for Public Disclosure of Adverse Events in Gene Therapy Trials

2000 ◽  
Vol 19 (2) ◽  
pp. 261-268
Author(s):  
Deborah R. Barnbaum
Keyword(s):  
Gene Therapy ◽  
Clinical Trials ◽  
Informed Consent ◽  
Adverse Events ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Public Disclosure

In January 2001, the Food and Drug Administration (FDA) proposed annual public disclosure of adverse events during gene therapy and xenotransplantation trials. The proposed policy raises the following questions: (1) Is the reformed policy in accord with the FDA's long-standing informed consent policies? (2) Why pair gene therapy trials and xenotransplantation trials in the revised guidelines? (3) Why single out these trials for public disclosure of adverse events? Each question is examined, and three conclusions are drawn. First, the FDA's own policies on informed consent require prompter public disclosure of adverse events. Second, the coupling of gene therapy and xenotransplantation trials entails a conceptual mistake in the types of communities that are harmed by each therapy's related adverse events. Third, all clinical trials merit such public disclosure of adverse events, not only gene therapy and xenotransplantation trials.

Regulation of Somatic-Cell Therapy and Gene Therapy by the Food and Drug Administration

1993 ◽  
Vol 329 (16) ◽  
pp. 1169-1173 ◽  
Author(s):  
David A. Kessler ◽  
Jay P. Siegel ◽  
Philip D. Noguchi ◽  
Kathryn C. Zoon ◽  
Karyn L. Feiden ◽  
...  
Keyword(s):  
Gene Therapy ◽  
Cell Therapy ◽  
Somatic Cell ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Somatic Cell Therapy
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