Safety Issues Dominate Pain Market

Pain relief has in some ways become, both linguistically and as an endeavor, a metaphor for the larger pharmaceutical industry. Today’s pain market is vibrant and growing, but more focused on risk avoidance or mitigation than on innovation As a […]

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Industry Tackles the New REMS Hurdle

A key element of the 2007 FDA Amendments Act (FDAA)—the change from “requested” post-marketing compliance plans to mandated Risk Evaluation and Mitigation Strategies (REMS)—has now come to the forefront for both newly approved and commercial biopharmaceuticals. While some REMS are […]

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PDMA Sharing Conference 2009

As we look forward to the 2009 PDMA Sharing Conference, there’s pride and satisfaction that comes with the knowledge that we will be celebrating our 20th anniversary in 2010. This September, we will be launching our two-decade milestone just as […]

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