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As the FDA ramps up its preparations for renewing PDUFA, industry and related groups are pushing for a greater focus on patient perspectives in its next iteration. Read More
Drugmakers and trade groups overwhelmingly want lower user fees and a clearer review process for GDUFA as the FDA looks to renew the user fees before the Sept. 30, 2017 cut-off date. Read More
The FDA has approved Acadia Pharmaceuticals’ Nuplazid to treat Parkinson’s disease in patients suffering from psychosis-related hallucinations and delusions. Read More