Accelerated Approval: US FDA Request For Makena’s Withdrawal Goes Beyond Failed Confirmatory Trial

 
• By Sue Sutter
  
Path of plated stones on gravel bed in Japanese Garden. Meditative stone walkway. Garden architecture, pathway accessory to garden pond.
US FDA is pursuing withdrawal so as not to damage the integrity of the accelerated approval pathway. • Source: Shutterstock

More from Post-Marketing Regulation & Studies

More from Product Reviews