There is much talk around the importance of clinical trials in finding new treatments and vaccines for COVID-19 patients, but observational studies in clinical practice also have a vital role to play, including the impact on pregnant women.
International regulators have agreed to increase their cooperation in three areas where observational studies of real-world data could be useful in the fight against the coronavirus pandemic, including research on the impact on pregnant women of the coronavirus itself and any treatments taken, as well as vaccine safety and efficacy monitoring.
“High-quality observational research is an important complement to the evidence on the safety and effectiveness of vaccines and treatments 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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
