The Food and Drug Administration may only be blowing smoke by prefacing a new drug-labeling rule with a purported pre-emption of state court suits against drug makers, but it’s gotten some lawyers hopped up and others steamed.
The source of the venting is a wordy preface to “Requirements on Content and Format of Labeling Human Prescription Drug and Biological Products,” 21 C.F.R. Parts 201, 314 and 601.
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