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FDA Raising Approval Bar For NSAID/PPI Combos; Endpoints Under Review

 
• By Kate Rawson

Regulatory briefings don't always just affect a single product; they can also be convened to discuss the regulatory parameters for a entire product class. One such briefing will be held in early 2009 to discuss the clinical trial design of NSAID/PPI combination products. Pozen is just one sponsor that will be affected by the outcome.

FDA is considering changes to the approval process for NSAID and proton pump inhibitor combination products that may result in the agency prohibiting the use of endoscopic gastric ulcer reduction to support a gastroprotective marketing claim.

That decision would raise the approval bar for a category of drugs that has recently become popular with certain companies: combining the pain properties of a non-steroidal anti-inflammatory drug with...

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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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