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

 
• By Kate Rawson

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.

When Novartis AG’s irritable bowel syndrome therapy tegaserod (Zelnorm) was found to carry an increased risk of cardiovascular adverse events last spring, drug review and drug safety officials at the Food & Drug Administration engaged in an intense internal debate over how to respond.

After much back-and-forth between officials at the Office of Surveillance & Epidemiology (drug safety) and the Office of New Drugs (drug review), the decision landed on the desk of then-Center...

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