Establishing multi-site network centers for rare diseases can help advance clinical research, but “onerous” regulatory compliance issues are a barrier that must be overcome, a clinical academic says.
Collaborative networks are a key way in which clinical trials for rare disease therapies can be made accessible to patients across the UK, but regulatory administrative burdens continue to pose significant problems, according to Simon Johnson, a professor of respiratory medicine at the University of Nottingham.
“You can't ask patients to come to centers hundreds of miles away, dozens of times throughout a trial. We need...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
