Hmmm ... the FDA has become to enamored of “best practice” documentation and process — so over the top — that it ignores reality. Reality, it seems is not a “best practice”.
Someone recently commented on TV that all of the government agencies are lacking leadership and direction and funding cuts have cost regulatory personal cuts.
Bush is a terrible manager, he would have a hard time getting a job managing a pay-less shoe store, and WE put him in charge of the government