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Three FDA investigators observed multiple quality lapses during a more than two-week inspection of Noven Pharmaceuticals’ transdermal drug manufacturing plant in Miami, Fla in November 2021. Read More
Johnson & Johnson (J&J) has agreed to pay $99 million to settle allegations that its Janssen subsidiary helped facilitate the opioid epidemic in West Virginia, just weeks after a trial got under way in the state. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) has issued draft guidance for industry on developing medicines that can be used for the treatment of celiac disease (CeD) along with a gluten-free diet. Read More