A new FDA Paradigm? Citing Guidances

February 28th, 2014 by

Just when you thought you had it straight, the FDA throws you a fast ball – or is it a slider, a spit ball. Not being a baseball fan, never quite certain what the saying is. Had I used the cricket analogy, I would have said a googly. But I digress.

Reading the new batch of FDA warning letters before my morning coffee, I came across an interesting paradigm breaker.

We all know FDA issues guidances and agrees to the ICH guidances. However, being guidances they are not law. That means that these documents and their contents are “suggestions” of practices they agree with. If you follow them they will give you no grief. They are really the path of least resistance. You can perform other practices and if satisfactory, you are OK. Just it might take more discussion during an inspection.

Now to the warning letter. It was issued to CBSCHEM Ltd of Hong Kong. In observation 1, they find fault in the traceability of the APIs. And which source of “regulation”?. The guidance ICH Q7 together with a hyperlink to the FDA website.

IS this the beginning of a new paradigm where they will cite Guidances?

Time will tell.

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