Sponsors should look beyond GCP training to identify, groom and qualify investigators for their trials. A White paper on improving measures of investigator qualifications from the Clinical Trial Transformation Initiative (CTTI), a joint non-profit venture of the FDA and Duke University, suggests sponsors avoid repetitive training and encourage investigators to improve new skills. Investigators should … Read more
Last week FDA announced that is has implemented a standardized, electronic semi-automated inspection protocol to GMP sites for sterile injectables with plans to expand the program to all GMP inspections or audits. The new GMP inspections protocol created under the New Inspections Protocol Project (NIPP) is a culmination of several years of planning, testing and … Read more
It came to light this week that Amazon has been developing software that could mine a patient’s medical records to help doctors and hospitals to “help patients and cut costs”. Similar software are being developed by Apple, Google, probably everyone else. Healthcare data is already available in various forms electronically and what is not, can … Read more
By now practically everyone has heard about the US-trained Chinese scientist who create gene edited embryos that led to twin girls. In the hoopla, one thing that is barely discussed is that how easy it was to do it. Using commonly available CRISPR-based gene editing technology, the scientist could create World’s first genetically engineered babies, … Read more
Last week Amarin announced the results of its large Phase 3 with the fish oil product, Vascepa. The trial showed remarkable improvement in cardiovascular events compared to placebo, however, patients on placebo showed higher than normal incidence rate for the same events that Vascepa is supposed to improve raising questions if the placebo over-inflated the … Read more
Last week FDA announced new ways to strengthen its expanded access program and, in the process, highlighted what an uphill task is has due to competition from the Right-To-Try (RTT) law. FDA released an updated webpage dedicated to the Expanded Access Program. The page describes in detail how “easy” and “fast” it is to request … Read more
A review of FDA’s webpage listing available Guidance Documents shows that in the last two years, the total number of available documents is steadily decreasing. This despite FDA having a full roster of new guidance documents being created and released. A screenshot in Oct 2017 showed 3164 active Guidance Documents on FDA’s website; a similar … Read more
Earlier this year, there was a major episode of pathogenic E. Coli contamination of lettuce grown in Yuma County, Arizona that led to hundreds of infections reported in about 36 states, and 5 deaths. FDA created an Environmental Assessment (EA) Team including members from the CDC, and local agricultural experts and found that the infections … Read more
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
