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ICON Insight: Leveraging Patient Registries To Assess Safety And Product Performance In The Post-Approval Arena
May 6, 2008
•ICON Newsletter — ICON Insight: Leveraging Patient Registries To Assess Safety And Product Performance In The Post-Approval Arena
The drug development path today is more challenging and expensive than ever. The cost of bringing a new drug to market is estimated at somewhere between $500 million and $1 billion. With this intense development investment, it's critical, then, for the drug to remain on the market after approval — an outcome that is not nearly as certain today as it was in decades past.
Indeed, the post-approval world that products and sponsors now face is fraught with complex — and shifting — requirements, guidances, and market forces. And these forces and demands are shaping the way sponsors approach both their research programs and their commercialization plans.
Growing Market Demand
The demand for post-approval information is being
driven by a global need for real-world data on product
safety, patient outcomes, and even treatment
costs — by regulators, payors, and providers alike.
Most notably, FDA- and EMEA-initiated safety-surveillance mandates have increased significantly in recent years; going forward, it's expected that most all products gaining regulatory approval will have at least one post-market commitment imposed. 2006 FDA data show, in fact, that 1,259 open commitments are currently held by only 127 companies — almost 10 commitments each.
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