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…
PhRMA urged the HHS inspector general to create a new safe harbor in anti-kickback regulations to directly address value-based payments and rebates. Source: Drug Industry Daily
The White House Friday confirmed that Scott Gottlieb will be nominated as the next commissioner of the FDA. Source: Drug Industry Daily
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