India and China have similar number of FDA-registered GMP manufacturing sites, 662 and 694, respectively. India and China manufacture similar kind of regulated products, primarily API and finished drug products, and very few biologics and medical devices. The two countries are culturally and economically quite similar as well. However, manufacturing sites in China have received … Read more
Clinical trial transparency has been a contentious issue between sponsors of trials wanting to protect their assets, and the other stakeholders, such as trial participants, demanding increased rapid disclosure. Per the clinical trial disclosure laws written in 2007, all clinical trials must be registered and their data published on clinicaltrials.gov. However, the quality of data published on clinicaltrials.gov … Read more
This week Presidential contender Senator Bernie Sanders announced that he would block Dr. Robert Califf’s nomination to lead FDA due to his “lack of commitment to lowering drug prices”. Doing this he joins Senator Markey who opposed Califf for approving opiates, and Senator Murkowski who is opposed due to labeling of genetically modified salmon. However, Mr. Sander’s … Read more
Since, 2007, it has been mandatory to register most clinical trials on the government clinical trial registry, clinicaltrials.gov. According to the same law, results of clinical trials must be posted within 12 months of the completion date. Failing to do either could lead to penalties of $10,000 per day till the violation is corrected. A survey of … Read more
Time and again it has been debated if the public funding into academic research is justified in terms of the “return on investment”, namely, does academia generates enough products for general use compared to the R&D labs in industry. In a recent opinion piece in Wall St Journal, it was suggested that scientific innovation is not … Read more
Clinical monitoring is the most expensive component of a clinical trial. More than half of the total budget of a given clinical trial is allocated for monitoring costs. Monitoring is essential for source data verification (SDV). Additionally, up to 80% of the time spent to manage a trial goes into the logistics and execution of … Read more
Patient recruitment challenges plague all clinical trials. Sponsors of clinical trials need to plan robust recruitment campaigns and involve creative solutions to find patients willing to participate in their trials. However, little systematic analysis has been conducted so far to evaluate the impact of poor recruitment on trial failure. That is till now. In a report published … Read more
Under PDUFA V, FDA committed to obtain patient perspectives on at least 20 disease areas and their treatment options by the year 2017. The purpose was to include patient perspectives on their conditions, its impact on daily life, and available therapies for better patient-focused and patient-centric clinical trials. FDA committed to hold public meetings to … Read more
Sometimes you see a new guidance document from FDA and you scratch your head, trying to understand the intent of this new document and then it dawns on you; FDA is trying its best to help the novice sponsors understand internal processes. Last week, FDA released a new Guidance Document on best practices to discuss with FDA, … Read more
About three weeks ago, on 16th November 2014, FDA released an internal report highly critical of Lab Developed Tests (LDTs) using 20 such tests as examples. This report highlights several of FDA’s concerns regarding LDTs. According to this report, unregulated LDTs are dangerous to the public not only by giving false positive or negative results, but also … Read more
