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Indian CRO Inspection Fall-Out: Semler's Clients Have To Repeat Studies For US FDA

 
• By Brenda Sandburg

In a rare move, the US Food and Drug Administration has sent letters to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) telling them that they will have to repeat bioequivalence and bioavailability studies conducted by the Indian contract research organization Semler Research Center Private Ltd. for their approved products and pending applications1.

In a rare move, the US Food and Drug Administration has sent letters to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) telling them that they will have to repeat bioequivalence and bioavailability studies conducted by the Indian contract research organization Semler Research Center Private Ltd. for their approved products and pending applications1.

The agency said that during an inspection of SRC's Bangalore facility it found the company's practices had "resulted 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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Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.