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US FDA seeks ways to improve accelerated approvals, as drug makers explain delays

 
• By Donna Young

The US Food and Drug Administration is holding a meeting on 8 February to review the reasons why five drug makers have failed to fulfil post-marketing confirmatory study commitments on time for drugs for which they received accelerated approval and to see whether it can provide advice about how to improve the efficiency of the expedited programme for cancer drugs1.

The US Food and Drug Administration is holding a meeting on 8 February to review the reasons why five drug makers have failed to fulfil post-marketing confirmatory study commitments on time for drugs for which they received accelerated approval and to see whether it can provide advice about how to improve the efficiency of the expedited programme for cancer drugs1.

The overall goal of the meeting, which is being held by the FDA's Oncologic Drugs Advisory Committee, is to optimise...

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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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New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 
• By Eliza Slawther

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

UK Pilots Faster Setup Of Early Phase Oncology Trials

 
• By Vibha Sharma

Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.

US CDC Vaccine Committee Revives Thimerosal Debate: A Portent Of Things To Come?

 
• By Bridget Silverman

The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.