The agency published guidance on the nonclinical evaluation of osteoporosis treatments.
On June 13, 2016, FDA released draft guidance on the nonclinical evaluation of treatments for osteoporosis. The guidance provides FDA’s recommendations for designing nonclinical studies of osteoporosis biopharmaceuticals.
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.
Source: FDA
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.