Food and Drug Administration

Endrocrinologic & Metabolic Drugs Advisory Committee

September 25, 2002


FDA's Osteoporosis Guidance, Dr. Eric Colman, MD, FDA   htm   ppt  

Post Menopausal Osteoporosis, Evolution of EU Guidance, Dr. Eric Abadie, MD, MBA, AFSSAPS, CPMP Vice Chair   htm   ppt

US Guidance for the Development of Drugs for Osteoporosis: Rationale, Durability and Evolution, Dr. Henry Bone, MD, Michigan Bone & Mineral Clinic   htm   ppt

Contribution of Preclinical Studies to Evaluation of Osteoporosis Therapy, Dr. Gideon Rodan, MD Ph.D., Merck Research Laboratories  htm   ppt

Preclinical Models of Drug Efficacy and Skeletal Toxicity, Dr. Rene Rizzoli, MD, Geneva University Hospital   htm   ppt

Determinants of Skeletal Fragility and Bone Quality, Charles Turner, Indiana University  htm   ppt

Relationship of Drug Associated Change in Bone Mineral Density to Fracture Risk, Dr. Marc Hochberg, MD, MPH  FDA   htm   ppt

The Size, Scope and Implications of Placebo and Active Controlled Trials, Dr. Steven Cummings, MD, FACP, Pfizer, Novartis, Organon, et al.   htm  ppt

Open Public Hearing

Challenges to Development of New Osteopororsis Agents, Dr. Ginger Constantine, MD, Wyeth, Research   htm   ppt

Statement by Dr. Willard Dere, Eli Lilly and Co.   htm   pdf   doc

Comments by Tom Marriott, NPS Pharmaceuticals, Inc.   pdf

Statement by Amy Allina, National Women's Health Network  htm   pdf   doc

GlaxoSmithKline Proposal for Amending the FDA Guideline for Evaluation of Postmenopausal Osteoporosis Therapies   pdf

Roche Position Paper, Clinical Endpoints for Osteoporosis Therapy Trials   pdf