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REMS, ‘Breakthrough’ Meetings Get ‘Type B’ Tag In Revised FDA Guidance

 
• By Brenda Sandburg

In other modifications, FDA tells sponsors seeking Type A meetings – the most urgent category – that data packages must accompany the request.

FDA has revised its guidance for formal meetings between the agency and drug sponsors to include discussions on “breakthrough therapy” products, Risk Evaluation and Mitigation Strategies (REMS) and post-marketing requirements.

The draft guidance, “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products,” revises a guidance issued in May 2009. The new document, announced in a...

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