This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
News|Articles|June 13, 2016
FDA Releases Guidance on Osteoporosis Treatment
Author(s)Pharmaceutical Technology Editors
The agency published guidance on the nonclinical evaluation of osteoporosis treatments.
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On June 13, 2016, FDA released
According to FDA, long-term nonclinical bone quality studies should be conducted for osteoporosis treatments because of concerns about long-term adverse effects of these drugs on bone quality and “because there are no validated and reliable methods for the noninvasive assessment of bone quality in humans.” The guidance addresses toxicology, bone quality, and biopharmaceutical nonclinical studies. Regulatory aspects and anabolic agents are also discussed.
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