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Final Guidance Clarifies Distribution Requirements For MedGuides

 
• By Cathy Dombrowski

Final policy on distribution of Medication Guides and inclusion in Risk Evaluation and Mitigation Strategies makes clear what FDA considers a material change.

One exception to FDA’s new policy of reducing requirements to disseminate Medication Guides is if there is a material change to the MedGuide, such as a new indication or new safety information, according to the agency’s final guidance.

“Medication Guides – Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)” explains how FDA will use discretion...

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UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

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Lerodalcibep And First Generic Palbociclib Among 10 New EMA Filings

 
• By Neena Brizmohun

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Welireg Among Japan Recommendations; Economic Policy Raises Hopes Of Higher Prices

 
• By Lisa Takagi

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