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Accelerated Approval: US FDA Writing Guidance On What ‘Ongoing’ Means For Confirmatory Trials

 
• By Derrick Gingery

Oncology Center of Excellence Director Richard Pazdur also says that he will not grant an accelerated approval if the confirmatory trial is not underway, even if the product shows safety and efficacy.

Richard Pazdur at Friends of Cancer Research Annual Meeting
OCE Director Richard Pazdur and other agency staff spoke about Project Confirm and other programs during the Friends of Cancer Research Annual Meeting. • Source: Screenshot of internet broadcast

Oncology sponsors soon will better understand the meaning of “ongoing” in the context of a confirmatory trial and the potential barrier it presents to accelerated approval.

OCE Director Richard Pazdur said 14 November that guidance on the meaning of “ongoing” is in development – and he also emphasized that without an ongoing confirmatory trial, an oncology...

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• 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.

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The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
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The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

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

 
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New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

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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