By: Observer
May I observe that the field inspection force had a significant hiring push in 2009-2010. (The tone of the post seems to reflect more the scientific and review staff at White Oak.) “Your USER FEES” at...
View ArticleBy: original industry insider
Gimme a break. I’ve been to many meetings in Rockville. Never once did I leave the building without the sun shining in my face. In fact that’s the trouble. You can’t get an afternoon meeting with these...
View ArticleBy: Observer
@oii – Please let me clarify my observation – the late sessions I mentioned were during inspection “visits” by FDA to company sites in both the US and EU. The field troops have a tendency to make their...
View ArticleBy: original industry insider
Now you are correct. FDA inspectors are very efficient in that regard and have a marvelous degree of cross training ability. Working in the midwest I used to hear of the same inspector checking out a...
View ArticleBy: Observer
@oii – may I observe that while your jocose (if familiar) reference … http://www.pharmalot.com/2011/03/which-drugmaker-fails-most-fda-inspections/#comment-607767 … to the food regs is a fine table...
View ArticleBy: anonymous
Rockville? CDER hasn’t had a industry meeting there in 5 years. I have recently worked in both industry and at FDA. The overall compensation is better in pharma for experienced professional staff. You...
View ArticleBy: original industry insider
Observer, point well taken. That software inspector checking the grapes. He must have been looking for “viruses”. Simply pathetic. Privatize the damn agency, put the towelheads out of their misery and...
View ArticleBy: anonymous
OII: LOL! I’ve been to that Holiday Inn CDER and CDRH are now located at the old Naval Surface Weapons site in White Oak on New Hampshire Ave. Since 2004. From what I understand, there’s not enough...
View ArticleBy: original industry insider
Good location. I’ve been hit by my share of ICBM’s lobbed by the agency.
View ArticleBy: Ben
There may be too much turnover in certain areas of the agency, but my observation is that key managers have a hammerlock on their jobs – in CDER anyway. As for fresh views, these guys are 100%...
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