iwewlkws FDA and EMA have been increasingly harmonizing regulatory requirements in Europe and US for most drug and biological products for the last two decades and it seems soon they may get even closer. This week European Medicines Agency (EMA) released a report disclosing ongoing discussions with FDA to set up ground rules for simultaneous review and approval of drugs, … Read more
The latest trend in clinical trial automation is use of BYOD, “Bring Your Own Device”, where a trial participant’s smart phone can be used to collect critical trial activities and data points such as patient diaries, symptoms, adverse events, drug supply management, and scheduling. Last year FDA released a guidance document on electronic informed consent; recently another … Read more
Challenges in recruiting patients are the most common reason for delays and increasing costs of clinical trials. This week the Clinical Trial Transformation Initiative (CTTI), a joint program between FDA, Duke University and industry representatives, announced recommendations for creating robust recruitment plans for clinical trials taking into consideration the most common challenges and potential solutions. CTTI also released … Read more
Clinical trial transparency has been a concern for a long time. An analysis by researchers at the University of Oxford found that more than 40% of the trial results published in the top 5 medical journals corresponded to new endpoints not included in the clinical protocol. In some case, none of the outcomes listed in the clinical … Read more
In an unprecedented bipartisan move, last week the US Congress passed 18 bills to curb opioid abuse, most of which will have a direct impact on how physicians prescribe these drugs. Along with the CDC recommendations for training and prescribing rules for doctors and the Comprehensive Opioid Abuse Reduction Act (CARA) passed earlier in March, these new laws highlight the various … Read more
Last December, we discussed how the snack bar company, Kind LLC, was first slammed by FDA for using “healthy” on its label and its fight to convince FDA to use current nutritional standards. This week, FDA reversed its decision and allowed the company to use “healthy” label on its packaging in relation to its “corporate philosophy,” not as a … Read more
Over the last few years, FDA has implemented several new pathways to expedite patient access to new drugs, biologics and medical devices. These programs, such as breakthrough designation, Fast Track review, Expedited Access Pathway and Priority Review, have significantly reduced the development and review time for new products. Faster approval adds more pressure on FDA to conduct … Read more
We hear occasionally about research articles that have been retracted due to faulty data or fraud. However, we seldom hear about overall impact of retracted articles. First, a given article may stay in publications for some time before it is retracted during which time it may be cited by others. Even after retraction of the article at … Read more
When we hear about data integrity issues these days, the obvious perception is of a facility in India or another foreign country getting caught trying to manipulate results. However, for a change (pun intended) this week we are talking about Theranos, a diagnostic lab in California with branches in Arizona and New Jersey, with serious data … Read more
This week FDA’s Advisory Committee (Ad Com) voted to reject Sarepta Therapeutics’ new drug for Duchenne Muscular Dystrophy (DMD) despite emotional pleas from patient groups and physicians in support of the drug. DMD treatments are eligible for most of FDA’s expedited approval pathways such as orphan drug designation, fast track designation, priority review status, and breakthrough designation. Sarepta had … Read more
