Introduction, Douglas Ws. Bierer, Ph.D., Director, Regulatory Affairs Worldwide Personal Health Care, Procter & Gamble pdf

Proton Pump Inhibition in the Self-Management of Heartburn, Donald O. Castell, M.D., Chairman, Department of Medicine, Graduate Hospital, Philadelphia, PA pdf

Omeprazole-Mg OTC Efficacy Program, Nora Zorich, M.D., Ph.D., Director New Drug Development, Procter & Gamble pdf

Consumer Usage Patterns in OTC Settings, Bernard P. Schachtel, M.D., Department of Epidemiology and Public Health, Yale University School of Medicine ppt htm

Safety, Douglas Levine, M.D., Chief Medical Officer, Gastrointestinal Therapeutic Area, AstraZeneca LP pdf

Summary, Nora Zorich, M.D., Ph.D., Director New Drug Development, Procter & Gamble pdf

FDA Presentation

Introduction and Efficacy, Larry Goldkind, M.D., Medical Officer, DGCDP ppt htm

Use Trials, Ling Chin, M.D., MPH, Medical Officer, DOTCDP ppt htm

Safety, Mark Avigan, M.D., Medical Officer, DGCDP ppt htm

Label Comprehension, Karen Lechter, J.D., Ph.D., DDMAC ppt htm

Charge to Committee, Linda Katz, M.D., MPH, Deputy Director, DOTCDP ppt htm

Charge to the Committee pdf doc

Tested Label pdf