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Australia’s Therapeutic Goods Administration is proposing expedited drug application reviews that would mirror programs in North America and Europe. Read More
The European Medicines Agency is investigating reports that India’s Wanbury Pharma, one of the largest exporters of the diabetes drug metformin, had more than half of its exports produced by an unlicensed supplier. Read More
Working groups representing both the generic and brand-name pharmaceutical industries told the FDA they need more guidance on how generic versions of abuse-deterrent opioid medications will be reviewed and approved. Read More
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