Researchers working on behalf of the EU’s public-private Trials@Home project offer insight into practices for direct-to-participant supply of investigational medicinal products in clinical trials.
The EU lacks harmonized regulatory requirements on how investigational medicinal products (IMPs) can be shipped directly to study participants instead of being dispensed at clinical trial sites, but this has not deterred trial sponsors from experimenting with different approaches on this front.
The most commonly deployed model is one with the least regulatory barriers in which the IMP is shipped from the...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
