Finland’s medical device function transfer goes ahead
This article was originally published in RAJ Devices
The transfer of Finland’s medical device regulatory functions from the National Agency for Medicines to a new welfare and health supervisory authority took place on 1 November1,2.
You may also be interested in...
The European public assessment report for Novartis's advanced breast cancer therapy, Piqray (alpelisib), includes some interesting insights into what EU regulators are looking for in drug company clinical trials.
A lower first dose boosted the vaccine’s efficacy result, but AstraZeneca has conceded that this has to be proven in a separate trial. In the meantime, the UK government has asked the regulator to assess the vaccine under a special health emergency provision.
The loss of fast-track status for setmelanotide at the European Medicines Agency means the review of the potential treatment of two rare genetic disorders of obesity will take longer than Rhythm Pharmaceuticals had originally hoped.