"During a recent FDA inspection, FDA noted that Crescendo did not have a written procedure for reporting adverse drug events. Crescendo told the Agency that it had not had any reportable events to date..."
Uh, if they don't have a procedure for reporting adverse events, it's no wonder that they don't have any reportable events. That would be like the police taking down 911, then claiming crime went down because they weren't getting any calls!
I'll end up going by the FDA findings, but that response is pretty much just spin, isn't it?
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Posted to FDA Takes Aim at Popular Scar Fading Gel on 27 Feb 2012
Uh, if they don't have a procedure for reporting adverse events, it's no wonder that they don't have any reportable events. That would be like the police taking down 911, then claiming crime went down because they weren't getting any calls!
I'll end up going by the FDA findings, but that response is pretty much just spin, isn't it?