REMS Assessment Review Goals, Resources On The Table For PDUFA VII

 
• By Derrick Gingery
  
Risk versus value matrix with pushpins and blur effect. Concept of investment risk assessment.
The FDA wants more PDUFA resources devoted to the REMS program to help speed up REMS assessment reviews. • Source: Shutterstock
Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from User Fees

More from Pathways & Standards