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Mandatory FDA Review Of Pivotal Trial Protocols Urged In JAMA

 
• By Sue Sutter

Dartmouth researchers say that although FDA recommendations can strengthen study designs and improve outcome measures, sponsors often don’t follow agency’s advice or don’t even seek input in Phase III design.

The quality of investigational drug pivotal studies would be enhanced by requiring FDA review of Phase III protocols and making the agency’s recommendations binding on sponsors, researchers say in the Journal of the American Medical Association.

Making agency review of pivotal study protocols mandatory and binding “may be even more important with increasingly flexible approval pathways,”...

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Swissmedic Launches Pilot To Expedite Clinical Trial Applications

 
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EU Countries Rally Behind Novel Pathway For Combined Drug/IVD Trials

 
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UK Pilots Faster Setup Of Early Phase Oncology Trials

 
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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.

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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

 
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CAR-T Therapy Trials Involving Chinese Labs Will Face Heightened US FDA Scrutiny

 
• By Michael McCaughan

The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.