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.
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.
The HAS, whose responsibilities include evaluating drugs for reimbursement purposes, is to set up a working group to look at...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
