On February 15, 2019, the U.S. Food and Drug Administration (“FDA”) finalized two guidance documents regarding regenerative medicine therapies (see FDA’s announcement here). This development comes nearly 14 months after FDA issued both guidance documents in draft form, which also coincided with FDA’s announcement of a new comprehensive regenerative medicine policy framework intended to spur innovation and efficient access to new regenerative medicine products.
FDA Commissioner Scott Gottlieb remarked that the finalization of regenerative therapy guidance ...
On January 19, 2017, the United States Food and Drug Administration ("FDA") unveiled a new drug designation process for regenerative advanced therapies, an important first step toward implementation of the regenerative medicine provisions of the 21st Century Cures Act. Products for which a designation as a regenerative advanced therapy ("RAT") is obtained are eligible for accelerated approval under the 21st Century Cures Act, which was signed into law by former President Obama on December 13, 2016 with sweeping bipartisan support.
The accelerated approval provisions for RATs ...
Blog Editors
Recent Updates
- New York’s Health Information Privacy Act Poised to Become the Latest in a Growing Trend of State Data Privacy Laws
- Effective Dates of DEA Final Rules for Telemedicine Prescribing Delayed
- Video: 2025 Outlook - the Department of Health and Human Services Under the Second Trump Administration – Diagnosing Health Care
- The NIH IDC – Where Are We Now
- False Claims Act Exposure in Focus: President Trump Signs Executive Order Targeting DEI Programs