The pharmaceutical industry has identified a range of statistical considerations relating to decentralized clinical trials that they want EU regulators to address to ensure data generated from such studies are acceptable for regulatory filings.
Drug companies are urging EU regulators to update their recommendation paper on decentralized clinical trials (DCTs) with advice on how to systematically evaluate the possible impact of decentralized elements on data quality and integrity.
The recommendation paper was issued in December 2022 to present the harmonized position of EU regulators on DCTs, which allow...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
