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Mid-June Launch For EMA’s Simplified Online Orphan Designation Filing System

 
• By Vibha Sharma

The European Medicines Agency will encourage companies to submit their orphan designation applications through a new portal when it is launched on June 15. Applications through existing processes will be accepted until Sept. 15.

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Companies Can File Applications Easily And Quickly • Source: Shutterstock

The European Medicines Agency is set to launch on June 15 a new secure online portal for drug companies to submit their orphan designation applications and to manage post-designation activities.

The new portal is being launched as part of an EMA-wide program to improve the way the agency records and manages master data and interacts with external stakeholders. The new...

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Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

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• By Vibha Sharma

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