federal_register: 2013-27769

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2013-27769 Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Extension of Comment Period Notice The Food and Drug Administration (FDA) is extending the comment period for the draft guidance for industry entitled "Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products" that appeared in the Federal Register of July 2, 2013 (78 FR 39736). The draft guidance document provides sponsors of Investigational New Drug Applications for cellular therapy (CT) and gene therapy (GT) products (referred to collectively as CGT products) with recommendations to assist in designing early-phase clinical trials of CGT products. In the notice, we requested comments on the draft guidance. We are taking this action to allow interested persons additional time to submit comments and to allow for public discussion at the February 25-26, 2014, Cellular, Tissue, and Gene Therapies Advisory Committee meeting, where FDA will present the draft guidance document for review. 2013-11-20 2013 11 https://www.federalregister.gov/documents/2013/11/20/2013-27769/draft-guidance-for-industry-considerations-for-the-design-of-early-phase-clinical-trials-of-cellular https://www.govinfo.gov/content/pkg/FR-2013-11-20/pdf/2013-27769.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is extending the comment period for the draft guidance for industry entitled "Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products" that...

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