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FDA’s Guidance Document To-Do List Grows

 
• By Brenda Sandburg

Since releasing its annual guidance agenda in December, FDA has added a number of guidances to its development agenda.

FDA’s Center for Drug Evaluation and Research plans to publish 50 new or revised draft guidances in calendar year 2012. The agency recently posted the current list of forthcoming guidances on its website. CDER ticked off three major items on the list when it issued draft biosimilars guidances last month Also see "FDA Biosimilars Guidances Address Immunogenicity Studies, European Bridge Data, Analytics" - Pink Sheet, 13 February, 2012.. The agency plans to issue one more biosimilars guidance this year. Below are some of the key documents in the works, which were not included in the annual guidance agenda FDA published in a December Federal Register notice Also see "FDA’s Guidance Document To-Do List" - Pink Sheet, 3 January, 2011..

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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.