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Shared REMS Systems Show Challenges Of Standardization – Could PDUFA V Help?

 
• By Sue Sutter

Hurdles to developing multi-sponsor programs include disagreements on design, decision-making and cost-sharing. PDUFA V initiatives on standardizing and integrating REMS could give FDA a means for providing more formal guidance or rulemaking on developing shared systems, as some in industry have requested.

FDA initiatives aimed at standardizing and better integrating Risk Evaluation and Mitigation Strategies into the health care system could provide the agency with an opportunity to address challenges that have arisen in the development of single REMS programs shared by multiple sponsors.

For the pharmaceutical industry, greater standardization and integration of risk management programs into the health care delivery system is likely...

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