FDA Enforcement Will Foster Developments of Safe, Effective Regenerative Therapies

November 1, 2019

(Pew Research Trusts) – Knowingly or not, many clinics offering cell-based therapies may be violating federal law and regulations governing the approval of new drugs, medical devices, and biologic products. FDA has taken important steps to prompt these businesses to comply with appropriate requirements, and the agency should continue enforcement activities to reduce and ultimately eliminate the marketing of unapproved stem cell products. As of May 2017, at least 716 clinics, spread across 45 states and the District of Columbia, offered unapproved stem cell products.