Prahsant Kumar Last year, Vanda Pharmaceuticals sued FDA for putting its clinical trial on partial hold for lack of nonclinical data from dog studies. This week, a federal court ruled that FDA has the authority to ask for any additional data that FDA’s reviewers deem necessary to lift the clinical hold. The court further ruled that Vanda … Read more
As hospital and insurance systems monetize their patient databases by selling data to information companies like Google, they should share some of the financial rewards with the patients to avoid being accused of exploiting patient data for personal gains, according to ethicists as the University of Pennsylvania. Google and other information technology companies are acquiring … Read more
Patient presentations at FDA Advisory Committee meetings are very important for swaying the votes of reluctant jurors to vote in favor of approval. Almost none of the patient presentations are against the drug under review and all of them are paid for by the company who product is being debated by the Advisory Committee. A … Read more
Several recent reports have pointed out that while the industry has become increasingly compliant with submitting results of clinical trials to clinicaltrials.gov, the academic centers are way behind. A new reports highlights that it is primarily due to lack of resources and support available to academic centers for doing the same. Posting results to clinicaltrials.gov … Read more
Data collected from wearable devices contain several sources of “noise” that reduce the reliability of such data in support of clinical/medical claims. A report this week presents a summary of the various factors that contribute to erroneous results and reasonable tips to address them. While the use of wearable devices in clinical trials has almost … Read more
It has been a few years since the infamous Martin Shkreli was in the news. And we have another opportunity to thank him for exposing (unintentionally, of course!) some of the worst secret practices of the drug industry. This time Mr. Shkreli shows how companies can use non-disclosure agreements and exclusivity contracts to artificially keep … Read more
A Federal judge in California ruled that FDA’s interpretation of its own Guidance Documents regarding autologous cell therapy is faulty and hence subject to legal challenge. Specifically, the judge ripped through FDA interpretation of the “same surgical process” exemption for the regulation of Human Cellular and Tissue-based Products (HCT/P). The case in point was a … Read more
The law requiring sponsors of clinical trials to post results from their trials to the clinicaltrials.gov website is almost 13 years old but many sponsors don’t care to comply and the government agencies responsible to enforce this law, NIH and FDA, have no plans to compel the sponsors to do so. Ironically, many trials with … Read more
The patients and doctors expect FDA to approve products based only on credible scientific data, but a few cases have shown that FDA does not always do that. In those cases, it falls on patients and their doctors to make sensible decisions based on facts before embarking on uncertain therapies carrying astronomical price tags. FDA … Read more
A couple of months back, there was a lot of hoopla when it became public that Google made a deal with one hospital chain to access personal medical data of millions of patients without patients’ consent. It seems that was but a tip of the iceberg. This week the Wall Street Journal reports that Google … Read more
