Regulatory rejection flurry does not make a storm

This week started with a bang for US regulatory action, with three complete response letters and two delays to an approval decision, a flurry that inevitably raised eyebrows. Whether the FDA is shifting away from what many believe is a permissive phase is a major preoccupation for biopharma.

However, the latest rejections take 2021’s CRL tally to 25, according to Evaluate Vantage’s calculations, meaning that this year is not shaping up to contain any more than previous years. This should provide some comfort to those in the business of getting drugs to market, though regulatory delay due to Covid-19 is still a live issue.