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FDA Week - 01/11/2019

SCOTUS Questions Clarity Of Warning Language In Drug Labeling Case

January 07, 2019
The Supreme Court on Monday (Jan. 7) heard oral arguments on a drug labeling case over whether drug maker Merck Sharp & Dohme Corp. should be held liable for injury to consumers even after FDA rejected the company’s proposal to include on its drug label warnings about potential fractures that could be caused by the osteoporosis drug Fosamax. The court on Monday debated whether FDA clearly understood Merck’s proposed wording and the seriousness of the risks, or whether the wording...


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