Newsletter - June 13, 2019
Clinicaltrials.gov has a Loophole that NIH and FDA Need to Close
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... Read More
Should FDA Disclose Submission of NDA and BLA Applications?
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. Read More
Clinicaltrials.gov has a Loophole that NIH and FDA Need to Close
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... Read More
Should FDA Disclose Submission of NDA and BLA Applications?
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. Read More
