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US FDA Sets Goal For Biosimilar, Drug Promotion Guidances

 
• By Brenda Sandburg

The US Food and Drug Administration's drug center plans to issue 102 new and revised draft guidances during calendar year 2016, including those on use of multiple endpoints in clinical trials, 180-day exclusivity, and abbreviated new drug application (ANDA) refuse-to-receive standards.

The US Food and Drug Administration's drug center plans to issue 102 new and revised draft guidances during calendar year 2016, including those on use of multiple endpoints in clinical trials, 180-day exclusivity, and abbreviated new drug application (ANDA) refuse-to-receive standards.

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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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