BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE
April 5, 2001
Briefing Information
Session I
Overview of Marcy 6, 2000 FDA Gene Therapy Letter Product Related Issues, Dr.
Joyce Frey Vasconcells
Overview of Marcy 6, 2000 FDA Gene Therapy Letter Multi Use Facility, QZ/ZC
Issues, Ms. Mary Malarkey
RCR and Different Packaging Cell Lines for Retroviral Vector Manufacture, Dr.
Carolyn Wilson
Testing of Plasmids as Manufacturing Intermediates in Gene Therapy Products, Dr.
Suzanne Epstein
Adenovirsu Vector Titer Measurements and RCA Levels, Dr. Steven
Bauer pdf html
Session II
Results of Gene Therapy Clinical Site Inspections, Ms. Elaine Cole, Mr. Joseph Salewski
Overview of Gene Therapy Surveillance Inspections, Joseph Salewski ppt html
April 6, 2000 Memorandum regarding April 13, 2000 conference call to discuss inspections pdf html
Bioresearch Monitoring and Surveillance and Gene Transfer Studies pdf html
March 6, 2000 FDA Gene Therapy Letter: Preclinical and Clinical Issues pdf html
Appendix A: Code of Federal Regulations, Title 21 Part 312.32-33 html
Appendix B: Code of Federal Regulations, Title 21 Part 312.50-60 html
Appendix C: March 6, 2000 FDA Gene Therapy Letter html
Appendix D: ICH Harmonized Tripartite Guideline, Guideline for Good Clinical Practice (ICH E6) pdf
Appendix E Checklist for Response to March 6, 2000 Gene Therapy Letter pdf html
Appendix F pdf