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U.S. Department of Health and Human Services

Advisory Committees

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2014 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee


November 6

The committee will discuss the draft guidance for industry entitled "Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products" and the Dear Gene Therapy IND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.


September 18

On September 18, 2014, from 1 p.m. to approximately 3:20 p.m., the meeting is open to the public. The committee will meet by teleconference. In open session, the committee will hear updates of research programs in the Laboratory of Biochemistry, Division of Therapeutic Proteins, the Laboratory of Molecular Oncology and the Laboratory of Molecular and Developmental Immunology, Division of Monoclonal Antibodies, Office of Biotechnology Products, Office of Pharmaceutical Sciences…