The upcoming EU requirement for summarizing clinical trial results in plain language is a real opportunity for companies to engage with the public. But if companies don’t provide clear and concise information, it may be reduced to a box-ticking exercise.
The setting of a clear implementation date for the EU Clinical Trials Regulation (CTR) has sparked calls for appropriate compliance with a new requirement in the legislation for companies to publish lay summaries of clinical trial results.
There is a concern that without a clear focus on ensuring that the lay summaries are “fit for purpose” –...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
