Day: October 24, 2018

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%). Inadequate drug accountability was … Read more

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’s rules for “deceptive” advertisement, “misrepresentations or … Read more