Results Wire: US FDA Advisory Committee Discusses Viral and Bacterial Shedding Guidance and the Dear Gene Therapy IND or Master File Sponsor Letters – NOV 6, 2014 (CTGTAC)
On Thursday, November 6, 2014, the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) discuss two topics: 1) the Draft Guidance for Industry titled, "Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products" and 2) the Dear Gene Therapy IND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.