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Re: misconduct6 post# 20852

Thursday, 07/22/2010 11:27:49 AM

Thursday, July 22, 2010 11:27:49 AM

Post# of 59550
Why is it so hard to consider that part of the onus for being unable to open the images is on the FDA?

In my personal experience working with a variety of government agencies from a consulting perspective, the following scenarios have happened:

1. Agency asked for document in X format, we provide in X and they say, "sorry we changed to Y format after our last meeting, please resubmit.

2. Agency asked for document in X format, we provide it in X and they say "Sorry, we need it in version X from 10 years ago. Please resubmit."

3. Agency asked for document and said "Send it in one of the following formats: x,y,z. We send it in Y and they say "Oops, we made a mistake, we can't open Y, please send it in X or Z".

4. Agency asked for document in Y, we sent it in Y, and they say "Sorry, our configuration of Y prevents us from opening files larger the B size in it. Could you resend it in G?

5. Individual from agency said "Give it to me in X." Three weeks go by, another individual says "Bob's gone now, I need it in Z."

Now in our case, these were predominantly electronic submissions so the resubmitall process is fairly quick, but it tooks days, sometimes weeks before we'd be notified by the agency there was a problem and often times even though there could be a quick workaround, the agency requested it brand new from us. Even when we were extremely proactive by confirming format just before submission, we still got caught by the above things because the decision making process in govt. is horribly slow. Our contact didn't know that format X was phased out, so he thought it was peachy and told us to use X until his superior told him.

When I look at this, I see run-of-the mill govt. IT systems and procedures.