Under pressure from all sides, the beleaguered Food and Drug Administration (FDA) keeps announcing new reorganization initiatives, name changes, and all sorts of stuff that would be funny if it was scripted by the same team handling Steve Carell’s departure from The Office and the ushering in of the new James Spader era.

Unfortunately, in real life these things aren’t always so funny. The FDA has been mocked in many quarters for its failure to maintain a balance between protecting the public safety and encouraging innovation among device and drug companies.

The list of FDA reorganization moves made in just the past year would fill pages of old-fashioned newsletter space, but suffice it to say that the FDA has made a lot of changes and shows no signs of stopping.

Question: Should device and drug manufacturers care?
Short answer: Yes.

Question: Do the FDA changes mean more inspections and enforcement action for device and drug manufacturers?
Short answer: Yes.

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