April 24, 2018
CryoStem Warning Letter

American CryoStem Gets a Warning Letter About Obvious Issues With Its Services

A lot of folks think that following the rules laid down by the FDA can be a challenge, due to the uncertainty of words used in 21 CFR 1271 or alleged ambiguities in the Agency’s guidances issued to assist stakeholders to follow the right regulatory path. But, in the case of American CryoStem Corporation (ACSC;...
Read More
Cord Blood Derived HCT

Cord Blood-derived HCT/Ps Remain ‘351 Category Products – Part One

Back in mid-February, I was at the IOF Conference and was a part of a panel discussing various aspects of the questionable regulatory compliance by companies selling products that contain cord blood-derived components, including viable cells, among other issues. I was shocked to learn of the extent that the free-for-all in regenerative medicine involved donor cord...
Read More