Need to Elevate Research Rigor Involving Regenerative Agents and Orthobiologics as Pain Treatments.

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    • Subject Terms:
      UNITED States. Food & Drug Administration
    • Abstract:
      The authors reflect on updates and issues regarding regenerative agents and orthobiologics as treatments for pain. They focus on the 2022 U.S. Food and Drug Administration (FDA) regulations, published resources, and the methods used to conduct quality research and safe patient care using said drugs. Also cited is the regulation of the agents as a drug, device, and/or biologic product.