Newsletter - October 25, 2018
FTC Steps in Where FDA Won’t: Regulation of Stem Cell Clinics by FTC
Last week FTC imposed an unprecedented $3.3 million fine on a stem cell business in California for making false claims about treating several diseases with its stem cell product. The business, called Regenerative Medical Group (RMG), and the physician running it, Dr. Bryn Henderson, were found to violate FTC' rules...Read More
FDA-MHRA GCP Workshop Highlights Key Trends in Data Integrity Issues
FDA and MHRA hosted a joint workshop on data integrity issues in GCP trials this week that described several interesting trends in US and non-US trials. The most common deficiency (61%) in GCP was due to the investigators failing to follow the clinical protocol, followed by inadequate and incomplete records (29%). Read More
FTC Steps in Where FDA Won’t: Regulation of Stem Cell Clinics by FTC
Last week FTC imposed an unprecedented $3.3 million fine on a stem cell business in California for making false claims about treating several diseases with its stem cell product. The business, called Regenerative Medical Group (RMG), and the physician running it, Dr. Bryn Henderson, were found to violate FTC' rules...Read More
FDA-MHRA GCP Workshop Highlights Key Trends in Data Integrity Issues
FDA and MHRA hosted a joint workshop on data integrity issues in GCP trials this week that described several interesting trends in US and non-US trials. The most common deficiency (61%) in GCP was due to the investigators failing to follow the clinical protocol, followed by inadequate and incomplete records (29%). Read More
