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