Accelerated Approval Withdrawals: Will Non-Oncology Indications Stop ‘Dangling’ In 2024?

 
• By Sue Sutter

While at least 25 accelerated approval cancer indications or drugs have been pulled or requested withdrawn since 2020, there has not yet been a similar concerted regulatory effort in the non-oncology space despite a large number of products with overdue postmarketing requirements.

referee
FDA Commissioner Califf compares FDA accelerated approval decisions to referees 'who don't always make the right call.' • Source: Shutterstock

More from Pink Sheet Perspectives

More from Pink Sheet