Renewal of FDA's Prescription Drug User Fee Act could be complicated by a federal court ruling that the agency must take action on Sandoz' application for a follow-on version of Pfizer's recombinant human growth hormone Genotropin
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Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.
Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.
A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.
