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Article: Food and Drug Administration's osteoporosis guidance document explained.
- Article from:
- Medical Letter on the CDC & FDA
- Article date:
- July 27, 2003
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2003 JUL 27 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration's osteoporosis guidance document has been outlined in the Journal of Bone and Mineral Research.
"In December 1979, the Food and Drug Administration's (FDA) Division of Metabolic and Endocrine Drug Products issued its Guidelines for the Clinical Evaluation of Drugs Used in the Treatment of Osteoporosis. The Guidance Document recommended study designs, patient populations for study, and techniques for evaluating skeletal mass and fracture frequency that were considered central to showing the efficacy and safety of drugs used to treat and prevent postmenopausal osteoporosis (PMO)," ...