A new scientific paper drawn up by experts on behalf of the EU public-private Trials@Home project discusses the pros and cons of various terms being used to refer to decentralized clinical trials and suggests a unified way forward.
While there is a growing interest in the adoption of decentralized elements in clinical trials, in which activities are centered around study participants rather than investigator sites, the lack of standardized terminology for such research can hamper meaningful discussions on this front.
A new paper, published in the scientific journal Drug Discovery Today, proposes doing away with terms like “remote” or...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
