The EU guideline on clinical investigation of medicinal products for psoriatic arthritis needs updating, including revised recommendations on the selection of the primary endpoint.
The European Medicines Agency is inviting stakeholder feedback on a proposal to update its 2007 guideline on psoriatic arthritis (PsA) to bring it in line with the current regulatory view on how the clinical development programs of such medicinal products should be designed.
The updated guideline, when adopted, is expected to help achieve consensus in the evaluation of PsA products by regulatory authorities,...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
