Amid the continuing conflict and the Russian shelling of hospitals in Ukraine, regulatory bodies, health authorities and clinical research organizations are issuing guidance on how to deal with the impact on clinical trials in both Ukraine and Russia.
EU regulators have advised sponsors with clinical trials under way or planned in Ukraine to deal with the inevitable deviations from trial protocols by using the regulatory flexibilities introduced during the COVID-19 pandemic.
Certain changes and protocol deviations are “unavoidable” amid the ongoing conflict in Ukraine, for example as a result of 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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
