NICE, the health technology assessment body for England and Wales, says it has seen “good uptake” of its new evaluation methods manual and real-world evidence framework, both introduced last year.
Real-world evidence (RWE) was discussed as a key topic during 40% of the technology appraisals conducted by NICE in the year since October 2022, while in 20% of cases it was accepted as the primary piece of evidence during health technology assessments (HTAs), a conference has heard.
Jacoline Bouvy, program director for medicines evaluation at NICE, the HTA body for England and Wales, told the NICE annual...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
