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US FDA's Presubmission Expedited Regulatory Programs Eyed For Streamlining

 
• By Sue Sutter

Agency staff, stakeholders see advantages to bundling requirements for fast-track and RMAT designations into a single, pre-breakthrough therapy pathway, and codifying processes and interactions that take place following award of breakthrough designation; proposal is aimed at reducing current programs' redundancies and maximizing benefit of frequent, early interactions with the FDA.

Confused undecided businessman watches the complicated road
There is interest in streamlining the US FDA's presubmission expedited pathways. • Source: Shutterstock

US Food and Drug Administration staff and stakeholders are discussing a potential redesign and simplification of the agency’s expedited regulatory programs to eliminate redundancy, better facilitate development of promising therapies, and address emerging drug development challenges.

One idea for reconfiguring the expedited development programs – fast track, breakthrough therapy and regenerative medicine advanced therapy – is to create a common entry point for drugs intended...

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US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
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EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
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EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
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EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
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EMA Rejects Treatments For Pediatric Myopia & CTCL

 
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