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Separate But Equal: FDA Reaffirms Drug Safety Role in Approval Process

This article was originally published in RPM Report

Executive Summary

There's a new drug safety structure at FDA, with the Office of Surveillance & Epidemiology gaining greater influence in how the agency manages things like REMS and product withdrawals. In many ways, it's a codification of an existing relationship between safety and review officials. But some sponsors worry it will also result in a less friendly approval process.

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