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Thursday, 09/23/2021 7:30:32 PM

Thursday, September 23, 2021 7:30:32 PM

Post# of 426289
OT, I was surprised to find this out. You would think ambulance chasers would have been all over this.

In 2015, The BMJ published a study from an FDA official that pulled out key points contained in 61 CRLs issued over a five-year period. Investigators compared those points to subsequent press releases issued by the companies that received those CRLs. Here are just a few highlights:

When the FDA cited safety or efficacy as a reason for not approving a drug, less than one-fifth of the statements were conveyed in subsequent press releases.
The FDA specifically called for new trials to confirm safety or efficacy in 32 of the letters, but just 19 were followed by press releases that disclosed the request.
18% of the CRLs issued weren't even followed by a press release disclosing the catastrophe.


https://www.bmj.com/content/350/bmj.h2758
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