September 28, 2020

The Niche

Knoepfler lab stem cell blog

FDA approval list

3 min read

The year of 2018 has already been a wild one for stem cell news. There are many developments on a variety of fronts. Here are some of the most notable news bites of the last month or so. RMAT Wave. The FDA continues its warp-speed issuance of Regenerative Medicine Advanced Therapy (RMAT) designations with 20 such designations now in the public domain with Cellerant Therapeutics’ announcement and possibly a few more not yet out there. I wrote about the “carrot” of RMATs as relative …Read More

3 min read

The Japan stem cell and regenerative medicine oversight system has been designed to move investigational therapies forward fast, much faster than the systems in other countries such as the U.S. But how well is it working so far? It’s an important question both for that country and more globally as the Japanese system was touted by some as a model and a reason why the U.S., to remain more competitive in this industry. Some of the same folks felt that the U.S. should also …Read More