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The administration’s plan to nominate Scott Gottlieb as FDA commissioner drew generally positive reactions on Capitol Hill and from drugmakers — but also some concerns from other stakeholders over his strong industry ties. Read More
The 505(b)(2) approval pathway, designed to expedite reviews, actually takes about five months longer than the standard NDA process, says a new report from the Tufts Center for the Study of Drug Development. Read More
PhRMA urged the HHS inspector general to create a new safe harbor in anti-kickback regulations to directly address value-based payments and rebates. Read More