Regulatory Shifts for HCT/P Products Put Orthobiologics Manufacturers on the Spot

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ARTICLE SUMMARY:

FDA’s shift in regulations is forcing companies to decide how much they want to commit to orthobiologics and in what ways. Zimmer Biomet’s decision to double down on one product in the near term, while halting work on another, indicates how it and other firms are assessing their strategies. Senior Director Joel Higgins talks about the impact of the new regulations on the company’s choices.

Last November, FDA issued a long-awaited, final guidance on its standards for overseeing human cell and tissue products (HCT/P). It is the latest coda in a decades-long, 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.

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