FDA turning conditional approvals to full faster than EMA: Data Byte

One of the major differences between FDA’s accelerated approval pathway and EMA’s conditional marketing authorization is that the latter requires annual reviews of companies’ progress on postmarketing commitments. While this suggests EMA’s system could do a better job of keeping companies on track, so far, data on conversions of conditional and accelerated approvals to full approvals finds a higher rate of conversions in the U.S.

The analysis below, which was conducted as part BioCentury’s annual Back to School project, dug into the promise and problems of expedited approval pathways around the globe and argued for a stretched vision of these pathways that would not only see them deployed in many more diseases outside of cancer but the entire premarket-postmarket continuum remade into a seamless learning system. ...