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Two House Democrats Tuesday asked the Government Accountability Office (GAO) to investigate the compounding pharmacy industry to look for gaps in federal and state oversight.
A district court has ordered the FDA to immediately approve Watson’s ANDA for a generic of Takeda’s billion-dollar diabetes treatment Actos.
The European Medicines Agency (EMA) has initiated its first-ever infringement procedure against a drugmaker, alleging Roche did not report potential adverse events for 19 of its U.S. drugs.
The FDA’s third annual review of backlogged postmarket requirements (PMR) and postmarket commitments (PMC) shows at least 58 percent of CDER’s reviews were fulfilled at the time of the most recent audit.
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