EC unit sets up workshops for candidate countries:
This article was originally published in Clinica
The European Commission's medical devices unit is convening two workshops with medical device and diagnostic regulatory experts from EU candidate countries which are due to become members next May. The first is scheduled for July in Budapest, while the second, focusing purely on vigilance and market surveillance, will be in Brussels in the autumn.
You may also be interested in...
FDA action awaits Sun’s manufacturing facility in Halol after it failed to adequately address GMP deviations, though India’s top-ranked drug firm appears to have effectively lowered its dependence on the site that has had a patchy compliance run.
In a surprise to the market, Dr Reddy’s and Hikma have prevailed in challenging six method-of-use patents shielding Amarin’s Vascepa in the US, opening the door for a potential at-risk launch that would likely be challenged by the originator.
Duo will study up to four novel preclinical targets identified by Sitryx that may lead to potential new drugs for autoimmune diseases, which Lilly would then commercialize.