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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
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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

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