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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