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Food and Drug Administration (FDA) › Pharmaceutical Industry › Notice of Violation

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Rock You Like a Migraine: OPDP Issues Notice of Violation for Misleading Representations in TV Ad That Promoted Popular Migraine...

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In 1984, the international rock band, The Scorpions, released the song, “Rock You Like a Hurricane.” Forty years later, the Food and Drug Administration’s Office of Prescription Drug Promotion rocked a pharmaceutical company...more

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Here We Go Again; FDA’s Back in Town Again: OPDP Issues a Second Notice of Violation in Less Than a Month

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Much like how Ray Charles lamented in 1967, the pharmaceutical industry is saying, “Here we go again, she’s back in town again,” as the Food and Drug Administration issued its second Notice of Violation in a month. Last week,...more

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Can’t Hardly Wait: OPDP Issues a Notice of Violation Where Risk Information Was Not Provided Adequately

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In 1987, the influential garage rock band, The Replacements, led by Paul Westerberg, sang, “I can’t hardly wait.” Years later, the Food and Drug Administration issued a Notice of Violation — the second this year — to a...more

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Double Vision: OPDP Issues Two Notice of Violation Letters in One Day

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Recently, the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued two Notice of Violation (“NOV”) letters in one day. Foreigner’s 1978 “Double Vision” album and title track come to mind. Both...more

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