STAT Plus: FDA extends deadline for stem cell clinics to comply with drug development rules
The Food and Drug Administration has pushed back by six months the deadline by which clinics that offer stem cell-based treatments must start complying with FDA drug development rules, citing the coronavirus pandemic.
The agency originally said in November 2017 that companies making stem cell products for patients had three years to start following FDA rules for developing treatments, including filing paperwork for clinical trials. The move was part of an effort from the FDA to distinguish between promising stem cell therapies that were following normal regulatory steps, and untested products pushed by unregulated clinics.
Continue to STAT Plus to read the full story…
