Sometimes a lead paragraph is too good not to borrow. Check this one out:

"It's been six months since the Center for Drug Evaluation and Research (CDER) division of FDA started requiring all electronic submissions to use the electronic common technical document (eCTD) format, and all is not well."

That's the take of Virginia Ventura of the FDA according to Bio-IT World. It's to be expected - I think. The technology used to produce eCTD's is new, the compilation and presentation procedures are new too. Anytime a whole lot of people have to change what they do at the same time, problems are a given.

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?

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?