In response to the U.S. FDA’s announcement today regarding its regenerative medicine policy framework, the Alliance for Regenerative Medicine (ARM) has issued the following statement:
Today’s action by the FDA is a significantly positive development for patients and their families. These guidances are further evidence of the FDA’s commitment to ensuring safe and effective treatments reach patients as quickly possible, while modernizing the agency’s regulatory approach to take into account the innovative nature of regenerative medicine products.
Therapeutic developers now have further clarity on the regulatory process requirements to meet the FDA’s high product approval standards. The ongoing implementation of the RMAT designation also is a boon to regenerative medicine and advanced therapy manufacturers, as they can apply to qualify for FDA’s expedited approval pathways, with special attention paid to the uniqueness of these products.
The framework, consisting of four guidance documents, two final and two draft, can be found here.
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, 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 270 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.