USA – US FDA’s latest medical device cybersecurity guidance: Key differences from previous versions
On April 8, 2022, the US Food and Drug Administration published a new draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of...
Europe – Commission seeks 5-year extension MDR/IVDR delegated acts powers
Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices 1 and Regulation (EU) 2017/746 of the European Parliament and of the Council on in...
UK – NICE recommends Janssen’s treatment for active psoriatic arthritis
Tremfya – also known as guselkumab – has been recommended by the National Institute for Health and Care Excellence (NICE) for people with active...
Europe – IA: la Commission européenne renforce l’exigence de garantie humaine
PARIS (TICpharma) - Le futur règlement européen sur l'intelligence artificielle (IA) devrait être finalisé "début 2023", signant le "top chrono" pour la mise en...
UK – ICR calls for further discussions following NICE’s rejection of breast cancer drug
Olaparib – a drug developed through UK-led and funded science – has been shown to cut the risk of cancer recurrence and improve survival...
France – Martine Wonner suspendue pour un an par l’ordre des médecins
La chambre disciplinaire du conseil régional de l’ordre des médecins du Grand-Est a annoncé, vendredi 25 novembre, la suspension pour un an des activités médicales...
