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French To Review The ‘Gamble’ Of Early Access Decisions

 
• By Ian Schofield

The Haute Autorité de Santé says that the risk of granting early access may only be justifiable if uncertainties over the clinical benefit of a drug can be addressed within a “reasonable” timeframe.

many question marks from the screen of tablet computer,
Early access schemes involve uncertainties over the clinical evidence • Source: Shutterstock

The French health technology assessment body, the Haute Autorité de Santé (HAS), is looking at how best to determine what data should be required before it allows early access to new, unapproved innovative medicines and how much time companies should be given to produce confirmatory data.

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Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 
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EU HTA Regulation: Don’t Forget About Vaccines, Industry Warns

 
• By Eliza Slawther

Europe’s vaccines industry wants to make sure immunizations “are not forgotten” by policymakers who are overseeing the EU Health Technology Assessment Regulation. It has highlighted several nuances of vaccines that should be addressed over the coming years.

More from Geography

ICH Modernizes Stability Testing Guideline

 
• By Vibha Sharma

The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.

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US CDC ACIP Puts GSK’s Penmenvy Even With Pfizer, Prepares For Infant MedQuadFi, Lyme Vaccines

 
• By Bridget Silverman

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