November 16, 2017

IMPORTANT NOTICE:

This information is intended for state, local, tribal, and territorial department of health regulatory and public health directors and officials.

Dear Colleagues,

Today the U.S. Food and Drug Administration (FDA) announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies.

The framework – outlined in a suite of four guidance documents – builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products. Further, two of the guidance documents propose an efficient, science-based process for helping to ensure the safety and effectiveness of these therapies, while supporting development in this area. The suite of guidance documents also defines a risk-based framework for how the FDA intends to focus its enforcement actions against those products that  raise potential significant safety concerns. This modern framework is intended to balance the agency’s commitment to safety with mechanisms to drive further advances in regenerative medicine so innovators can bring new, effective therapies to patients as quickly and safely as possible. The policy also delivers on important provisions of the 21st Century Cures Act.

The two final guidance documents clarify the FDA’s interpretation of the risk-based criteria manufacturers use to determine whether a product is subject to the FDA’s premarket review.

·        Final Guidance: Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use: https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM585403.pdf

·        Final Guidance: Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception: https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM419926.pdf

The two draft guidances provide important information to help spur development and access to innovative regenerative therapies.

·        Draft Guidance: Evaluation of Devices Used with Regenerative Medicine Advanced Therapies:

https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM585417.pdf

·        Draft Guidance: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions:

https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM585414.pdf

For more information, please refer to FDA’s news release, or contact Lorrie McNeill, Director of the Office of Communication, Outreach and Development at FDA’s Center for Biologics Evaluation and Research, at lorrie.mcneill@fda.hhs.gov.

This message is being broadcast by the Division of Communications in the FDA’s Office of Regulatory Affairs (ORA).

Thank you,

FDA/ORA

Office of Communications and Project Management

Division of Communications

Mailbox:  DivComm-ORA@fda.hhs.gov