Better data linkage and data entry systems could transform Germany’s clinical cancer registries into a reliable data source for health technology assessments.
With some improvements, clinical cancer registries that exist in every federal state in Germany could be an important new source of comparative data to support submissions for new oncology products undergoing Amnog benefit assessments, according to Volker Vervölgyi, division head of the drug assessment department at IQWiG, Germany’s health technology appraisal institute.
Vervölgyi’s comments follow the publication of a study on using registries to gather better data for the assessments. The...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
