Material is organized by meeting date, with more recent meeting first.
December 14, 2010
On December 14, 2010 from 3 p.m. to approximately 5 p.m., the committee will meet by teleconference. In open session, the committee will hear updates of the research programs in the Tumor Vaccines and Biotechnology Branch, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, FDA.
November 19, 2010
On November 19, the Committee will discuss current FDA recommendations for Testing of Replication Competent Retrovirus (RCR)/Lentivirus (RCL) in Retroviral and Lentiviral Vector Based Gene Therapy Products.
- Agenda [ARCHIVED]
- Announcement [ARCHIVED]
- Briefing Document — Testing for Replication Competent Retrovirus (RCR)/Lentivirus (RCL) in Retroviral and Lentiviral Vector Based Gene Therapy Products — Revisiting Current FDA Recommendations (PDF - 128KB) [ARCHIVED]
- Draft Agenda [ARCHIVED]
- Minutes [ARCHIVED]
- Presentations [ARCHIVED]
- Waivers for Conflicts of Interest [ARCHIVED]