PDUFA VII Could Increase Transparency Of REMS Release Process

 
• By Derrick Gingery

Proposed commitment letter language included a look at eliminating REMS, potentially to more clearly outline the process.

Hand turning a knob to select low risks investment. Concept of risk and reward ratio. Composite image between a hand photography and a 3D background.
The PDUFA reauthorization could shed more light on the REMS elimination process. • Source: Shutterstock

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