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.
French To Review The ‘Gamble’ Of Early Access Decisions
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.
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