BioCentury
ARTICLE | Regulation

Quantifying overlap in FDA and EMA expedited approvals

Though they agree one third of the time, the two agencies often make different decisions on the same data

September 1, 2021 1:15 PM UTC

The U.S. and EU are expediting a similar number of drug approvals and converting the initial approvals to full approval at a similar rate. But a drug-by-drug analysis shows the two regulators often make different decisions on the same products.

BioCentury identified 196 drugs approved under the expedited pathways, of which 57 (29%) received an expedited approval in both territories. The analysis included a drug’s first approval only and excluded accelerated approvals of supplemental indications...



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