If It's Technically Deficient- It's Not Here
July 16, 2007

If It's Technically Deficient- It's Not Here --- so says the FDA. It matters not if you made a small mistake that can be corrected in a minute or a huge mistake that takes days, the submission isn't received until it has passed a technical validation check to ensure that it can be opened, processed, and archived.

What will it cost you?

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Timing is Everything. Or is it?
December 4, 2006

First a disclaimer: We're not Regulatory Affairs Professionals and we don't play them on television, so it should be clear to anyone who reads this blog that anything we write (with the exception of news on RA jobs and careers) is based on what we've read or heard.

Our intention with the Regulatory Affairs section of this blog is to facilitate conversation and to report on what we believe to be factual but quirky items. Hence our first entry:

Timing is everything, or is it?

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