The EU’s new trial portal and database system, which allows the submission of a single application to conduct a study across any number of EU countries, has yielded its first fruit in the form of an approval for a non-commercial Swedish clinical trial involving cardiac arrest patients.
The first clinical trial has been authorized through the EU’s new Clinical Trial Information System (CTIS), which came onstream at the end of January this year, when the provisions of the Clinical Trial Regulation (CTR) also took effect.
The trial is entitled Vasopressin and Steroids in Addition to Adrenaline in Cardiac Arrest – a Randomized Clinical Trial (VAST-A)....
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
