iwewlkws 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
A review of ten years of FDA database on dietary supplements tainted with drugs shows that supplements intended for sexual enhancement, weight loss and muscle building accounted for more than 95% of the tainted products. There are more than 100,000 dietary supplement products available in the US accounting for annual sales of more than $140 … Read more
Drug and biologics intended to treat rare diseases require better planning and due diligence due to unique challenges posed by smaller target populations. In a new guidance document released this week, FDA lists several common sense measures for sponsors prior to conducting the first-in-human studies with such products and suggests that these be discussed at … Read more
A review of doctor’s habits for relying on diagnostic tests without fully understanding them shows that doctors increasing use results of diagnostic tests incorrectly. Diagnostic tests are over-prescribed and highly trusted, without appreciating the probabilistic nature of diagnostic tests. If well-trained professionals can be misled by the results of the diagnostic tests, one can argue … Read more
In industry-funded clinical trials run by academics, the industry participants play an important role in the design, conduct and reporting of the trials, a fact appreciated by more than 90% of the academic collaborators. In a survey published last week, researchers reviewed critical decision processes regarding Phase III and IV clinical trials lead by academic … Read more
The list of planned Guidance Documents is a good indicator of FDA’s priorities for the coming year. Each year each center at the FDA publishes the list of Guidance Documents it plans to publish or draft next year. CDRH’s list of Guidance Documents shows that software-based products are the top priority of the Center this … Read more
Traditionally, when making changes, updates or improvements to Class II devices approved under the 510k process, the developers had to file a new traditional 510k for the updated device. Under a pilot program launched earlier this week, FDA expanded the special 510 process to include most modifications of previously approved 510k devices. The special 510k … Read more
There has been a lot of criticism over the years of both FDA and NIH for not enforcing the laws for reporting clinical trial results on clinicaltrials.gov. Last week FDA announced a process for penalizing companies and individuals under the same law. It has been more than 10 years since the Food and Drug Administration … Read more
