Food and Drug Administration
Oncologic Drugs Advisory Committee
September 24, 2002
Briefing Information
NDA 21-399, IRESSA® (gefitinib)
Disclaimer
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
Briefing Document, Dr. Ronald Falcone, PhD, AstraZeneca Pharmaceuticals LP pdf
Team Leader Comments and Regulatory Background, FDA doc htm pdf
Medical Officer Review, FDA doc htm pdf
Addendum A to Statistics contained in the Medical Officer Review doc htm pdf
Addendum B to statistics contained in the Medical Officer Review doc htm pdf