iwewlkws The news of questionable science and data integrity issues at Theranos has filled prime time news for several months. Critics have variously chastised the company for all aspects of its operations. However, the blame for this does not rest only on Theranos; the industry as a whole made major mistakes in not checking one of its own. But there … Read more
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
Patient perspectives could be vastly different from that of the drug developers and regulators in terms of the benefits and risks of existing therapies, the medical need and relevant endpoints for clinical trials. In the recent years, FDA has aggressively courted patients to provide opinions about the regulatory review process through its Patient Focused Drug Development … Read more
Wearable devices such as smart watches, fitness devices, smart phones and mobile phone apps, and other such gadgets can be used to collect useful health-related information about the individual using them. It is often thought that using such devices one can track important clinical trial information and increase accuracy, speed and reliability of data. Recently, … Read more
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
