Regulatory Open Forum

If you are interested in drug development trivia, participate in Vivpro Brain Teasers that we release every Tuesday.

This week's question:

In 2022, 35 of the 129 CDER NDA/BLAs had Orphan Drug Designation. How many of those were approved under the Accelerated Approval regulation?

Participate here

https://www.linkedin.com/feed/update/urn:li:activity:7033784279260110849/

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Pravin Jadhav
CEO
Lansdale PA
United States
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This week's question:

Keytruda: Of the 133 sBLAs since the original approval in 2014, how many were #Accelerated Approvals AND #Breakthrough designations?

Participate here:

https://www.linkedin.com/feed/update/urn:li:activity:7036337353296113664/