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FDA Review “Program” Tweaks May Include Smaller Mid-Cycle Meetings

 
• By Kate Rawson

Mid-cycle meetings under FDA’s review “Program” have ballooned into 30- to 40-person affairs – far larger than originally envisioned under PDUFA V. Those numbers – which can sometimes include the entire FDA review team – have made mid-cycle conference calls difficult to schedule, especially for expedited products with tight review timeframes. It is one lesson learned from the first 18 months of the Program.

WhenTakeda Pharmaceutical Co. Ltd. executives called into a mid-cycle communication teleconference with the Food & Drug Administration to discuss the status of the Entyvio (vedolizumab) BLA for ulcerative colitis and Crohn’s disease, they found quite an audience on the other end of the line: no fewer than 24 representatives from FDA, including three high-ranking agency officials.

That isn’t what FDA or industry had in mind when a requirement for a “mid-cycle communication” was included in the...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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EMA Learns Hard Lessons From US-Inspired Streamlining Pilot

 
• By Vibha Sharma

The European Medicines Agency’s ongoing pilot to streamline drug reviews by allowing companies to voluntarily pre-fill factual data in assessment report templates appears to add significant workload for industry, without delivering clear value to regulators.

UK Drug Pricing Scheme Talks Collapse: Industry Braces For Another Year Of High Rebates

 
• By Eliza Slawther

Talks between the UK government and the pharmaceutical industry that were intended to resolve issues around high clawback rates under the voluntary pricing scheme for branded medicines have failed, meaning that the mechanism used to calculate rebates will remain in place.

US FDA Suspends Valneva’s Ixchiq Based On Four New Serious AE Reports

 
• By Sue Sutter

After an Aug. 6 safety labeling change, the FDA became aware of “more compelling evidence” that the risk for serious chikungunya-like illness is not limited to older adults, CBER Director Prasad said.