federal_register: 2013-15797

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2013-15797 Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled "Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products" dated July 2013. The draft guidance document provides sponsors of Investigational New Drug Applications (INDs) for cellular therapy (CT) and gene therapy (GT) products (referred to collectively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. 2013-07-02 2013 7 https://www.federalregister.gov/documents/2013/07/02/2013-15797/draft-guidance-for-industry-considerations-for-the-design-of-early-phase-clinical-trials-of-cellular https://www.govinfo.gov/content/pkg/FR-2013-07-02/pdf/2013-15797.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled "Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products" dated July 2013. The...  

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