FDA Releases Guidance on Osteoporosis Treatment
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On June 13, 2016, FDA released draft guidance on the nonclinical evaluation of treatments for osteoporosis.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
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
