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Could Judges Require Independent Experts To Explain Biosimilars?

Executive Summary

Biologics and biosimilars could cause courts to no longer blindly trust FDA’s scientific judgment, likely creating a whole new headache for the agency as companies go to court to challenge regulatory decisions.

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Agency chief counsel says continued priority-setting through lawsuits eventually may affect public health, while professor says FDA discretion not to act is at stake in some cases.

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