The Alliance for Regenerative Medicine Submits Comments to FDA’s Draft Guidance on Minimal Manipulation

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ARM requests additional clarity on a number of points within the guidance and recommends the FDA hold a public hearing to facilitate discussion with stakeholders.

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The Alliance for Regenerative Medicine (ARM), the international organization representing the regenerative medicine and advanced therapies industries, submitted its comments today in response to the FDA’s draft guidance entitled “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products,” published for comment on December 23, 2014.

As the international advocate for its multi-stakeholder member base of more than 200 companies, research centers and organizations, patient advocacy groups, investors and more, ARM promotes policies intended to support research and commercialization of advanced therapies and regenerative medicine products.

“We’re pleased to see the FDA provide additional insight into their regulatory decision-making process on this important topic,” said Michael Werner, executive director of ARM. “We do ask, however, that the FDA provide clarity on a number of important points within the guidance, given the complexity, significance and impact of this issue. We also encourage FDA to hold a public hearing to engage with stakeholders in a full airing of the topic.”

Further information needed on the term “main function”

In its filed comments, ARM requests more information on the concept, origin and application of the draft guidance’s inclusion of the new and yet-undefined term “main function” of the human cells, tissues, cellular and tissue-based products (HCT/Ps) when assessing minimal manipulation, as these products may have more than one function and it is not clear which of these functions would be considered primary.

Given the focus on the “main function” to determine regulation, ARM also asks for further insight on the regulatory treatment of certain processes, including cryopreservation or freezing; how a minimally manipulated autologous tissue can be combined in the operating room; how grinding, micronization and/or decellularization impacts the minimal manipulation assessment; and more.

ARM also encourages the FDA to address the issue of EU regulatory harmonization in its finalized guidance, offering examples where differing definitions of “minimal manipulation” require further explanation and insight.

Taking industry views into account

The FDA’s finalized guidance will have significant impact on many stakeholders in the advanced therapies community; ARM recommends the FDA hold a public meeting to facilitate discussion.

By law, the FDA must respond to comments. Once finalized, the guidance will replace the September 2006 document “Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update.”

The draft guidance is available online here: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM427746.pdf.

For more information about ARM, please visit alliancerm.org.

About The Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 200 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visit http://www.alliancerm.org.

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Michelle Linn
Linnden Communications
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