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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
The FDA served drug manufacturer Amneal Pharmaceuticals with a Form 483 after an inspection found the company failed to submit all adverse drug experience reports on time. Read More