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On April 8, 2022, the US Food and Drug Administration published a new draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of...
UK – GSK’s Omjjara recommended by NICE to treat myelofibrosis patients with anaemia
The agency’s final draft guidance applies to both newly diagnosed and previously treated patients, although those eligible will need to have either not been...
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...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 September 2023
New safety information for Omega-3-acid ethyl esters
The PRAC agreed to add atrial fibrillation (irregular, rapid contraction of the heart) as a common side effect to the product...
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...
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...
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...
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...