By: David Egilman
Is this the same Pfizer that is subject to a corproate accountability agreement? Another DOJ look the other way event. Holder will not catch a contempt citation over this one.
View ArticleBy: Retired Director
Pulses. Everyone who has ever worked with pharmaceutical promotional materials knows they must submit them to the FDA via fda form 2253. And this company is operating a corporate integrity agreement?
View ArticleBy: KLieberthal
The very first paragraph of the letter confirms that a 2253 had been filed as required. After a drug is launched the only mandate is to send OPDP a copy of a new promotional piece before its first use....
View ArticleBy: Ed Silverman
Hi TedW, Thanks for the note, although I’m not sure of your point. I did not write that Pfizer had not submitted the necessary form or had done so, but at an incorrect time. The point I tried to make...
View ArticleBy: original industry insider
Let’s not split hairs here. The promotional material was clearly violative. Note, however that this was an untitled letter, aka NOV or Notice of Violoation, meaning that the agency did not consider the...
View ArticleBy: John S. Campana
You can give a placebo to a group of patients and you will have a number of said side effects. Some will say that constipation was a problem. Others will say nausea or upset stomach. Some will say it...
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