science-based tradition behind them. Compliance and science would be joining hands better, and the regulated industry would find it more palatable.

We are not all the way to the point that you have described, because in fact, the only part of CBER inspections done in the field environment is blood and blood product inspections; and now that is limited primarily to the annual inspections, not the preapproval inspections. Interestingly, however, the primary motivation for doing that was itself uniformity. This shows how we sometimes chase ourselves around in a circle.

Richard Swanson: The organizational chart presents only a part of the picture. Communications occur not only through solid and dotted lines. The Field Biological Committee has an interface across many avenues. Enforcement and inspection must be a team effort, and so the formal lines are interconnected with additional communications.



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