WASHINGTON, DC, September 12, 2016 – The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the cell and gene therapy and broader regenerative medicine sector, submitted written comments today in response to the FDA-issued draft guidances relating to the regulation of human cells, tissues or cellular or tissue-based products (HCT/Ps).
The FDA will hold a public hearing September 12 and 13, 2016, soliciting feedback from various sector stakeholders regarding the guidances’ scope, issues covered and included recommendations. ARM Executive Director Michael Werner will present a summary of ARM’s written comments at the hearing today.
“ARM commends the FDA for holding this public meeting,” said Werner. “How FDA defines and applies these regulations is critically important to our sector, providing transparency and insight into the approval process and ultimately ensuring safe and efficacious products reach patients as soon as possible.”
As the leading advocate for more than 240 member companies, academic research centers, life science investors, patient groups and more, ARM represents a wide variety of sector stakeholders, including manufacturers of products regulated under Section 351 and 361 of the Public Health Services Act. Products under Section 351 require FDA marketing authorization; those under Section 361 do not.
In its submitted comments, ARM requests further explanation on the requirements for product characterization and related claims for each type of product, including examples of how FDA will define and apply key terms, including “minimal manipulation,” “homologous use” and “main function” when evaluating various technologies.
ARM also suggests FDA adopt the use of flowcharts and other public communications tools to provide insight into the step-by-step understanding of how FDA approaches evaluation of these products and rationale for its regulatory decisions.
ARM’s summary of its submitted comments is available here. For more information about ARM, please visit www.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 240 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.
# # #
