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Drugmakers need to shift from phased, single-drug clinical trials toward a new paradigm of collaborative assessments of multiple drugs based on biomarkers, CDER Director Janet Woodcock said Tuesday, using the ongoing breast cancer trial I-Spy 2 as an illustrative example.
An FDA advisory committee Wednesday voted to recommend approval of Merck’s insomnia drug suvorexant, pointing to trial data showing the drug is effective in helping patients fall, and stay, asleep.
A Senate committee Wednesday advanced without controversy two bills, one reforming federal oversight of compounding pharmacies and the second establishing a nationwide track-and-trace system for pharmaceuticals.
One week after settling a long-running compliance case with the Justice Department, Indian drugmaker Ranbaxy trumpeted a list of quality “enhancements” it is making that closely track manufacturing recommendations FDA officials persistently promote to prevent problems.
A patient death and safety reports of hypersensitivity reactions to AMAG Pharmaceuticals’ flagship iron deficiency drug Rienso has prompted a one-batch recall.