FDA+ roundup: CDER's breakthrough designation requests see steep decline in 2021; Drugmakers call to expand FDA guidance on PD-(L)1 dosing
The once never-ending rise of breakthrough designation requests at the FDA slowed again in 2021, with just over 100 requests coming into the agency, compared to 156 just two years ago.
In addition to the decline in requests, there was also a substantial drop off in approvals: FDA hasn’t approved this few of requests — 41 were granted in FY 2021 — since 2015. And the agency’s 39 denied requests are the fewest of any year since the breakthrough program was created in 2012 by the Food and Drug Administration Safety and Innovation Act.
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