Articles at Specialty Medical Center in Sterling Heights, and Dearborn, MI

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FDA announces comprehensive regenerative medicine policy framework

Framework aims to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy

Focus Area: Regenerative Medicine

Regenerative medicine refers to a general approach to restore, replace, or recreate cells, tissues, or organs to treat or mitigate disease.

Tissue and Tissue Product Questions and Answers

FDA regulates human cells or tissues intended for implantation, transplantation, infusion, or transfer into a human recipient.

Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use

Guidance for Industry and Food and Drug Administration Staff

The Role of the FDA in Ensuring Safe Pain Management Solutions

Explain how the FDA’s policies and regulations support the development of safe and effective regenerative medicine treatments for pain. Comparing Traditional and Regenerative Pain Management Techniques