In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine.” Continue Reading FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine Policies

On Tuesday, President Obama signed the 21st Century Cures Act (the “Act”) into law.  The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product development, and health care delivery enterprises. Our colleagues have previously discussed the Act’s many provisions that aim to speed up the process of bringing new drugs and devices to market. One of the Act’s most significant amendments to the Federal Food, Drug and Cosmetic Act will allow FDA to grant accelerated approval to regenerative medicine products, while also providing the Agency with wide discretion on creating new approaches to regenerative medicine. This legislative development is historic given increasing pressure from patients and other stakeholders to move regenerative medicine advancements more quickly from the lab into the clinic. Continue Reading President Obama Signs 21st Century Cures Act; Creates Accelerated Approval Pathway for Regenerative Medicine

This week, a high-profile FDA hearing sought to receive broad stakeholder input on four draft guidance documents from 2014 and early 2015 that further explain the agency’s views on some of the criteria for the regulation level of Human Cell and Tissue Products (HCT/P) as well as on the scope of the “same surgical procedure” exception under 21 CFR § 1271.15. More than 150 people attended in-person, including our own Joanne Hawana, with another 500 webinar attendees. Continue Reading FDA Concludes Two-Day Public Hearing on Human Cell and Tissue Product (HCT/P) Regulatory Paradigm