Policy Papers Outline CDER’s Role in Assessing REMS Plans
Two newly revised FDA policy papers outline how CDER will evaluate Risk Evaluation and Mediation Strategies (REMS) and REMS Assessment Reports.
Source: Drug Industry Daily
Two newly revised FDA policy papers outline how CDER will evaluate Risk Evaluation and Mediation Strategies (REMS) and REMS Assessment Reports.
Source: Drug Industry Daily