Advisory Committees

2011 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee

Advisory Committee Meeting Materials:

November 17, 2011

On November 17, 2011, the committee will discuss Apligraf (Oral), Organogenesis, Inc., BLA 125400, for the treatment of surgically created gingival and alveolar mucosal surface defects in adults.

September 22-23, 2011

On September 22, 2011, the committee will discuss BLA 125397, Umbilical Cord Blood, New York Blood Center, indicated for hematologic malignancies, bone marrow failure, primary immunodeficiency diseases, beta thalassemia, Hurler syndrome, Krabbe disease, and X-linked adrenoleukodystrophy. On September 23, 2011, the Committee will discuss HDE BH110018...

June 29, 2011

The Committee will discuss cellular and gene therapy products for the treatment of retinal disorders. Topics to be considered include the following: (1) Efficacy endpoints in pediatric and adult populations, (2) potential safety issues related to repeat administration or second eye administration, and (3) evaluation of product delivery into target site.

May 31, 2011

On May 31 from 2:30 p.m. to approximately 6:15 p.m., the Committee will meet by teleconference. In open session, the committee will hear brief overviews of research programs in the Laboratory of Biochemistry, Division of Therapeutic Proteins, Center for Drug Evaluation and Research; and the Laboratory of Cell Biology, the Laboratory of Molecular and Developmental Immunology, the Laboratory of Molecular Oncology, Division of Monoclonal Antibodies, Center for Drug Evaluation and Research, FDA.

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