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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
The Drug Controller General of India asked manufacturers twice last year to submit Phase IV trial protocols— once in June and again in September — but most drugmakers have still not fulfilled the regulatory requirement. Read More