iwewlkws As of last week, FDA has fully implemented its Mutual Recognition Agreement (MRA) with the European Union (EU) whereby FDA and regulators from all 28 member countries of the EU would share GMP inspection findings at drug manufacturing sites. The MRA is but the first step to integrating GMP audits across various regulators to avoid … Read more
Should FDA officials be restricted in what jobs they can pursue after leaving office? A few days after leaving the FDA, the last Commissioner Scott Gottlieb joined the same venture firm he left to join FDA. Then a few weeks later he joined the Board of Pfizer. In that he joined the long tradition of … Read more
Three out of four new drugs approvals by FDA use expedited approval pathways making faster than normal review by FDA the normal process compared to it being used only for exceptional cases about 10 years ago. Also, more than half of the new drugs approved by FDA are for life-threatening diseases and unmet medical needs. … Read more
A prominent blog this week speculated why India seems to be becoming an attractive place for developers of Artificial Intelligence (AI) based medical technology. India offers some obvious advantages to developers over other countries in the region, however, one must consider some important lessons from the recent history of the clinical trial industry in the … Read more
Most clinical trials struggle to recruit diverse populations. Use of Real World Evidence (RWE) may offer the solution to this problem. Despite active encouragement and a few guidance documents from FDA about the importance of diversity in clinical trial populations, almost all the new products approved by the FDA in the last decade were based … Read more
A study released this week reported that common home-based smart listening devices like Amazon Echo and iPhones could be used to detect cardiac arrest based on irregular breathing sound. The authors show how everyday common devices can be used not only to detect cardiac arrest with a greater than 97% sensitivity and specificity but that … Read more
FDA has maintained officially that cannabidiol (CBD) is regulated as drug and hence it is illegal to add CBD to food and dietary supplement while at the same time letting thousands of CBD containing food and supplement products sells openly. CBD is the active ingredient of one FDA-approved drug, Epidiolex, but is available in thousands … Read more
FDA is not allowed by law to report submission of NDA and BLA applications or when it rejects these applications, but submitters do. In more than 97% of the times, companies announce via news releases, SEC filings or both, the submission of their market approval applications. A publication by FDA officials in JAMA this week … Read more
Over the last two decades Clinicaltrials.gov has become an invaluable archive of all clinical trials where one can easily register a clinical trial, few questions asked; and that’s the problem. It has also become home to dubious and illegal clinical trials. There are trials pretending to be credible by virtue of being listed on a … Read more
Traditionally FDA officials have avoided directly inserting the Agency in discussion on the ethics of high drug prices, till this week. This week, the FDA commissioner (acting) made an off-hand comment at a conference that seems to justify the $2.1 million price tag on a recently approved gene therapy from Novartis. He said that the … Read more
