Food and Drug Administration
Endrocrinologic & Metabolic Drugs Advisory Committee
September 25, 2002
Slides
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