Commission to review MDD (Medical Devices Directive) comments in April:
This article was originally published in Clinica
The European Commission will formally consider responses to its questionnaire to member states on the performance of the Medical Devices Directive in early April. Medical device regulatory authorities in each of the EU member states were sent the questionnaire as part of the Commission's five-year directive review programme.
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.