The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notices of availability for six draft guidance documents relating to the development of human gene therapy products that appeared in the Federal Register of July 12, 2018. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments and any new information.
Document
Draft Guidances Relating to the Development of Human Gene Therapy Products; Availability; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notices of availability for six draft guidance documents relating to the development...
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Federal Register Citation
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83 FR 45249
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“Draft Guidances Relating to the Development of Human Gene Therapy Products; Availability; Extension of Comment Period,” thefederalregister.org (September 6, 2018), https://thefederalregister.org/documents/2018-19303/draft-guidances-relating-to-the-development-of-human-gene-therapy-products-availability-extension-of-comment-period.