Three months after hearing testimonies of patients who suffered severe side-effects from the use of quinolones and fluoroquinolones, the European Medicines Agency has recommended that some of these medicines should be removed from the market and the labeling of others should be changed to restrict their use.
Major changes are in store for sponsors of quinolone and fluoroquinolone antibiotics in the EU. The European Medicines Agency has issued recommendations to remove some of these medicines from the market and to change the labeling of others to severely restrict their use in patients due to concerns of potentially long-lasting side effects.
The recommendations were issued this month by the EMA’s pharmacovigilance committee, the PRAC, following a public hearing earlier this year...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
