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NDA User Fees Will Climb Almost 16% On Oct. 1

 
• By Derrick Gingery

US FDA completes updates for biosimilars and novel drug fee schedules as PDUFA VI is set to begin.

FDA entrance sign 2016

With less than three weeks to go before the launch of the new user fee cycle, the US FDA has officially announced the rates that sponsors of biosimilars and novel drugs will have to pay.

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Another Regeneron CRL Prompts Regulatory Operations Questions

 
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PharmaMar Seeks EU Fast-Track Status For ‘Practice-Changing’ ES-SCLC Therapy

 
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PharmaMar, which wants to use the Jazz Pharmaceuticals-partnered drug, lurbinectedin, in combination with Roche’s Tecentriq for treating extensive-stage small cell lung cancer, is one of two companies that this month sought an accelerated assessment of their planned EU marketing applications.

US FDA Miss On Stealth’s Elamipretide Boosts Signal Of Broader Delays Due To Staff Cuts

 
• By Sue Sutter

Failing to meet the 29 April user fee date for the Barth syndrome treatment, and CDER’s request for a delay in responding to Vanda’s appeal of a tradipitant complete response letter, suggest a slowdown in review work due to layoffs and other recent changes.

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Another Regeneron CRL Prompts Regulatory Operations Questions

 
• By Alaric DeArment

CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.

UK Mandates Unmodified Standardized Contracts To Speed Clinical Trial Set-Up

 
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The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.

Canada’s HTA Agency Reveals How To Submit AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.