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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

FDA is approving new drugs and medical devices too fast, its reviewers are leaving for jobs in the industry they regulate, and it is critically short on resources, the editors of the New York Times opined this week. Another article this week in the Journal of American Medical Association (JAMA) by Harvard researchers, raised similar … Read more

The high cost of healthcare in the US is often blamed on the high cost of prescription drugs, however, a recent study showed that the administrative costs play a much bigger role in our increased medical bills. The US healthcare costs is often compared to that in Canada, with laws being created to reimport drugs … Read more