USA – New FDA guidance offers ethical roadmap for including children in clinical trials
The US Food and Drug Administration (FDA) has issued draft guidance outlining a series of ethical considerations for conducting clinical trials that involve children.
The guidance,...
China – Un robot miniature biodégradable pour l’administration ciblée de médicaments
La libération ciblée de médicaments aux emplacements souhaités est difficile dans le tractus gastro-intestinal en raison de l'environnement acide/alcalin de l'estomac et des intestins,...
UK – UK regulator MHRA to raise medical device registration and other fees by...
The UK Medicines & Healthcare Products Regulatory Agency (MHRA) has published a consultation for industry comment regarding a proposed increase in fees the agency...
Japan – Japan’s MHLW updates medical device program display code and labeling laws
Japan’s medical device regulators have updated regulations and implementation guidelines for enforcement of the PMD Act and bar code labeling laws. Manufacturers should become...
Spain – Des applis mobiles pour prédire le risque d’exacerbations de BPCO et détecter...
BARCELONE (TICpharma) - Des applications mobiles utilisant l'intelligence artificielle (IA) apparaissent comme des outils d'aide à la prédiction des exacerbations de bronchopneumopathie obstructive chronique...
France – Comment la médecine in silico peut accélérer l’innovation en matière de DM
La complexité des dispositifs médicaux modernes croît avec l'amélioration de leurs fonctionnalités, qui représentent un bénéfice pour les patients, mais augmentent également les risques...
France – Comment apporter une preuve clinique suffisante pour se conformer au RDM ?
Le Règlement 2017/745 (RDM) a considérablement augmenté la place des données cliniques dans le processus de certification des Dispositifs Médicaux (DM), en comparaison des...
Europe – MDCG 2022-15 : Guidance on appropriate surveillance regarding the transitional provisions...
Article 110(2) and 110(3) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) state that devices which are covered by valid certificates...
Brazil – ANVISA announces major medical device registration updates
Brazil’s medical device market regulator, ANVISA announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001. The changes will serve...
USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms
The US Food and Drug Administration (FDA) has released a finalized list of alternatives and streamlined mechanisms for current good manufacturing practice (CGMP) of...
