I have gone into this detail occasionally here, because constantly repeating it is burdensome, but there is a difference between guidances that have the effect of imposing a meaningful burden upon the public -- like the AD FDA decisional guidance -- and procedural or supportive, advisory guidances.
Only guidances that indirectly assume a regulatory requirement are treated by the courts as similar to regulations. These require due process in creating, changing, or revoking them, while the others do not. You may have noticed the FDA has been using rulemaking procedures for the draft guidance we are discussing. That's why.
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