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Of 1,583 postmarketing trials required to be performed from fiscal years 2008 to 2014, only 373 trials or 23.5 percent, were completed by the end of fiscal 2014, according to a new report from the FDA. Read More
The Federal Trade Commission is backing Mylan in its request for a rehearing before a panel of appellate court judges on the dismissal of the company’s antitrust case against Warner Chilcott and Mayne Pharmaceuticals. Read More
The FDA’s new Inspection Protocol Project is expected to increase the likelihood of a drug manufacturing facility undergoing a pre-approval inspection from the current 30 percent to a target of 50 percent. Read More