Quantifying overlap in FDA and EMA expedited approvals

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...