Table of Contents
ADVAIR and FLOVENT DISKUS Supplements for the COPD indication: SUMMARY and QUESTIONS Mary Purucker, MD, PhD Medical Team Leader Division of Pulmonary and Allergy Drug Products CDER, USFDA
OVERVIEW
EFFICACY SUMMARY
SAFETY ISSUES
ICS and COPD: AERS Database
ICS Systemic Effects: Bone (1)
ICS Systemic Effects: Bone (2)
ICS Systemic Effects: HPA Axis
ICS Systemic Effects: Ocular
Conclusions
Agency Concerns for Discussion by PADAC: EFFICACY
Agency Concerns for Discussion by PADAC: SAFETY
Acknowledgements
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Author: Tunde Otulana
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