NOV 6 CTGTAC

Briefing Summary: US FDA Posts Advisory Committee Materials on Viral and Bacterial Shedding Guidance and the Dear Gene Therapy IND or Master File Sponsor Letters – NOV 6, 2014 (CTGTAC)

The US FDA has posted details, including FDA Briefing Materials, for the Thursday, November 6, 2014 meeting of the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC). The committee will discuss the following: 1) the Draft Guidance for Industry titled, "Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products" and 2) the Dear Gene Therapy IND or Master File Sponsor Letter.

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