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Picture Is Worth 1,000 Meetings: ‘Snapshots’ Could Support ‘Breakthrough’ Dialogue At US FDA

 
• By Michael McCaughan

US FDA’s Oncology Center of Excellence is eager to pilot test ‘Drug Development Snapshots’ as a potential tool to optimize communication for drugs receiving the Breakthrough Therapy Designation. That may be an early next step in the effort to enhance the expedited pathway.

• Source: Alamy

The US Food & Drug Administration sounds ready to test the idea of having sponsors submit a high-level overview of plans and objectives in specific drug development areas like dosing as a mechanism to further improve interactions to support “Breakthrough” drug development.

The proposal to pilot test “Drug Development Snapshots” as a new communication tool is one proposal offered in a Friends...

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More from Pathways & Standards

US FDA Acting Drug Center Chief Corrigan-Curay Retiring, Senior Staff Remake Continues

 
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The news coincides with rumors that Commissioner Martin Makary soon will name a new Center for Drug Evaluation and Research director.

EU Pharma Reform: Lawyers Unpack Diverging Visions For Innovation

 
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