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

This week, a high-profile FDA hearing sought to receive broad stakeholder input on four draft guidance documents from 2014 and early 2015 that further explain the agency’s views on some of the criteria for the regulation level of Human Cell and Tissue Products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

Looking back on 2015, it’s apparent that this was another very busy year for the Food and Drug Administration (FDA or Agency), whose oversight responsibilities are estimated to touch 25% of American consumers’ spending on various regulated products.  There was no shortage of significant Agency actions in 2015 related to therapeutic and diagnostic products, which include traditional chemical drugs, biological products, medical devices and diagnostic tests, and even stem cell therapies and human tissue products.  Also noteworthy is that FDA is reporting that as of December 14th it had granted approval to 42 groundbreaking new drugs (called “new molecular entities” or NMEs) and therapeutic biological products during the calendar year.  The figure so far for this year beats 2014’s final count of 41 approved NMEs and far exceeds the prior year’s total of 27 NMEs.  This post will highlight some of FDA’s significant actions this year and provide our thoughts about what next year may bring for FDA-regulated entities.
Continue Reading FDA Legal and Regulatory – 2015 Year In Review