FDA explains why it denied about 60% of non-oncology breakthrough therapy requests from 2017 to 2019
The FDA is offering a look into why it denied about 60% of all breakthrough therapy designation requests it received from the biopharma industry — outside of oncology — between 2017 and 2019, according to a recent analysis of BTD approvals and denials.
CDER officials Atasi Poddar, Miranda Raggio and John Concato explained in a paper published last week in Therapeutic Innovation & Regulatory Science how 30% were denied for a single reason, while 70% were denied for multiple reasons.
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