EU drug regulators have received some candid responses from trial sponsors and other stakeholders on the aspects that should be urgently addressed in the next iteration of their guidance on decentralized clinical trials.
EU regulators looking for feedback on what stakeholders made of their recommendation paper on decentralized clinical trials, which was issued nearly a year ago, have been flooded with suggestions for improvement, starting with keeping an open mind and not holding DCTs to a higher degree of scrutiny than conventional site-based trials.
Regulators were told to refrain from “making assumptions” on what patients or principal investigators might prefer in a trial, and...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
