A Draft Guidance. Tell Me What Not How

Just a quick post, the first for quite a few months, on a new draft FDA guidance. Back in late December 2010, the FDA released the first draft of an electronic source data guidance and now we have an updated document.

The first point to note is that the guidance is still draft and this is rather unusual. Normally we get the draft, comments are submitted and then the guidance is issued in its final form. To me this suggests that the initial draft guidance did not quite hit the mark the first time around.

The new draft can be found here  and the associated Federal Register notice here. Comments are to be submitted by 22nd January 2013.

I have read through the new draft and I cannot say I am too impressed. The main issue I have with the document is that it is still very much a “how” document rather than a “what” document. By this I mean, it is not telling me what I want to achieve, it is trying to dictate how I should achieve it. As such, it has a high chance of failing, as technology will move forward and the guidance will stay firmly where it is when it is finally issued.

I would suggest the agency goes and has a look at the EMA guidance document, but then I am totally biased.

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