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How To Speak REMS: Structured Product Labeling Seen As Route To Standardization

 
• By Cathy Dombrowski

“Before we can standardize REMS we need to have that common language to describe what’s in the REMS,” FDA’s Adam Kroetsch says.

Structured Product Labeling is gaining momentum as the path to standardized Risk Evaluation and Mitigation Strategies.

FDA, drug companies and other stakeholders in the health care system view standardization as the best way to lower the burden of REMS on health care providers while ensuring the...

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