FDA seeks comment on plan to increase REMS transparency

FDA seeks comment on plan to increase REMS transparency

Source: 
RAPS.org
News Tags: 
snippet: 

The US Food and Drug Administration (FDA) is seeking to be more transparent about its Risk Evaluation and Mitigation Strategy (REMS) program.

The agency is seeking public comment on its plan to publish its evaluations of how individual drug and biologics sponsors are doing on the implementation of REMS programs.