Last November, FDA issued a long-awaited, final guidance on its standards for overseeing human cell and tissue products. It is the latest move in an ongoing effort by the agency to wrap its arms around the complex, evolving, and controversial area of tissue-based biologics and, by extension, the newer, fast-growing field of regenerative medicine. An excerpt from Senior Writer Wendy Diller’s October 17 feature, “Regulatory Shifts for HCT/P Products Put Orthobiologics Manufacturers on the Spot.”
The stem cell therapies market is booming, thanks to ongoing unmet clinical needs, demographics, marketing, and advances in technology, but medical professionals are grappling with lack of evidence for most applications. Senior writer Wendy Diller explored stem cells’ use in orthopedics in our June 27 issue, and noted the exponential growth of financing for companies in the field.