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FDA Commissioner Scott Gottlieb spent the early weeks of his tenure in the agency’s top job laying out his priorities before senior FDA staff and members of Congress and announcing the agency’s hiring freeze had officially been lifted. Read More
President Trump’s budget for fiscal 2018 proposes a “recalibration” of how the FDA funds its core mission of ensuring the safety and quality of drugs, which would cut federal spending by $854 million, to be replaced with $866 million in industry user fees. Read More
FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure in mid-May, aligning inspection staff into seven product categories — more closely mirroring the organization of the agency’s centers and ultimately moving to what may seem like stricter inspections, especially at first. Read More
The nation’s largest pharmacy benefits manager, Express Scripts, has sued Kaleo — maker of Evzio, an injectable emergency treatment for heroin and painkiller overdoses — claiming it owes nearly $15 million in fees and rebates. Read More
Ohio’s attorney general filed a lawsuit against Purdue Pharma, Endo Health Solutions, Teva, Johnson & Johnson and Allergan this week, alleging they contributed to the opioid epidemic through fraudulent advertising. Read More