Day: June 13, 2019

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