Perspective: Don’t Worry… after All, What Can FDA Do To Us?

Quite a lot, actually!

Something that I often hear as I travel around the country preaching quality systems, agency guidance and best practices is some variety of, "I read the regulations and it does not say we have to do that, so we will not." Often, the person making that pronouncement is a lawyer or an MBA with little experience in the real world of regulated industry and who has no personal knowledge of the range of tools the US Food and Drug Administration (FDA)-or any regulatory body-has at its disposal to make life difficult for recalcitrant firms.