FDA Gene Therapy Draft Calls for Long-term Follow of Subjects.
The FDA recently issued multiple draft guideline documents on the fast-emerging field of gene therapy, including guidance on specific diseases like hemophilia and the need to follow some research subjects long-term to assess delayed adverse events.
| Published in: | IRB Advisor Vol. 18; no. 9; pp. 97 - 109 |
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| Main Author: | |
| Format: | Journal Article |
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Relias LLC
Sep2018
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| Online Access: | View this record in EBSCOhost |
| Summary: | The FDA recently issued multiple draft guideline documents on the fast-emerging field of gene therapy, including guidance on specific diseases like hemophilia and the need to follow some research subjects long-term to assess delayed adverse events. |
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