The European Medicines Agency is re-examining the use of valproate in women to address ongoing safety concerns and will hold its first ever public hearing later this year to listen directly to the experience of EU patients with these medicines.
The European Medicines Agency’s pharmacovigilance committee has finally found a suitable candidate for its first ever public hearing on the safety of marketed medicines. It has decided to get public input on the use of the anti-epileptic drug valproate in women and girls who are pregnant or of childbearing age.
The precise date of the hearing will be decided in June, and details of interested persons who can register for...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
