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Massachusetts Judge: FDA Withheld, Delayed Agency Action On Warning Labels

Mealey's (September 10, 2018, 1:23 PM EDT) -- BOSTON — In a Sept. 5 grant of summary judgment in favor of the American Academy of Pediatrics (AAP) and other health organizations, a Massachusetts federal judge compelled the U.S. Food and Drug Administration to promulgate a final rule implementing Section 201(a) of the Tobacco Control Act (TCA) (American Academy of Pediatrics, et al. v. United States Food and Drug Administration, No. 1:16-cv-11985, D. Mass., 2018 U.S. Dist. LEXIS 150595).

(Decision available.  Document #04-180919-030Z.)

According to U.S. Judge Indira Talwani of the District of Massachusetts, the...
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