Category Archives: compliance

BBC Takes Aim at GSK Corruption

GlaxoSmithKline’s legal wrangle concerning corrupt practices in Poland was one target of a pharma expose by the BBC’s flagship current affairs show Panorama this week. The program featured an interview with a former GSK sales rep based in Lodz, who said doctors were paid to promote GSK’s asthma drug Seretide. It was “a simple equation”, […]
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Compliance Congress: Walking the Line

Pharma industry executives, FDA officials and Department of Justice attorneys speaking last week at CBI’s 11th annual Pharmaceutical Compliance Congress (PCC) offered solutions and threats to companies hoping to avoid enforcement actions.
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Confessions of a Compliance Director

In anticipation of CBI’s (a PharmExec sibling company) 11th Annual Pharma Compliance Congress happening later this month, PharmExec spoke with a compliance director at a mid-sized pharma ($5 billion in annual sales) about life under a CIA, and the potential trigger issues for 2014. In an effort to promote candor and avoid overly circumspect responses, […]
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Deep Breadth: GSK Doubles Down on COPD and Asthma

Will GSK be able to maintain its position in COPD and asthma, post Advair/Seretide? Despite a patent expiry in 2010, generic versions of Advair aren’t expected to appear on the market for two more years. It took FDA eight years to develop a blueprint for how generics manufacturers might establish an acceptable bioequivalence for Advair, […]
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Provider Demand to Drive Compounder Registration with FDA

The Food and Drug Administration is moving fast to implement the drug compounding provisions of new Drug Quality and Security Act (DQSA), issuing new guidance to spur registration by outsourcing facilities just days after President Obama signed the new bill into law. But because FDA cannot compel compounders to opt for agency regulation, implementation will […]
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