The committee will discuss the Draft Guidance for Industry entitled "Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products" and the Dear Gene Therapy IND or Master File Sponsor Letter.
The committee will discuss the Draft Guidance for Industry entitled "Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products" and the Dear Gene Therapy IND or Master File Sponsor Letter.