Regulators often diverge from FDA on expedited oncology approvals

RAPS

22 June 2026 - Among oncology drugs first approved by the US FDA, other regulatory authorities varied in how they approved the same products, both in terms of the regulatory frameworks and the evidentiary thresholds used as the basis for the approvals, according to recent research published in Frontiers in Pharmacology.

Regulatory authorities such as the EMA were more likely to approve the same products but based on a higher evidentiary threshold, while the TGA was more likely to agree with FDA analyses of pivotal trials but on a longer timeline, researchers said.

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Michael Wonder

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Michael Wonder