Europe – PRAC Strategy on Measuring the Impact of Pharmacovigilance Activities (Revision 2)

Pharmacovigilance activities and the regulatory actions taken by competent authorities based on emerging pharmacovigilance data are designed to lead to changes in knowledge and...

Europe – EMA medical terms simplifier

This compilation gives plain-language descriptions of medical terms commonly used in information about medicines. Communication specialists at EMA use these descriptions for materials prepared...
Spécificités méthodologiques d’évaluation clinique des Dispositifs Médicaux Connectés

France – Covid-19 : la HAS intègre les vaccins bivalents dans la stratégie de...

La HAS confirme sa recommandation d’administrer une dose additionnelle de vaccin contre la Covid-19 aux personnes à risque de faire une forme sévère de...
NICE ‘OK’ for Lynparza

UK – Takeda’s Exkivity receives NICE recommendation for rare form of lung cancer

The treatment was licensed through by Project Orbis, an international programme to review and approve promising cancer drugs helping patients access treatments faster. NICE’s decision...

USA – FDA finalizes multiple endpoints guidance

The US Food and Drug Administration’s (FDA) on Thursday finalized guidance to sponsors on managing multiple endpoints in clinical trials to minimize the likelihood...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – European Commission Decision Reliance Procedure (EC DRP) extension

European Commission Decision Reliance Procedure has been extended by 12 months to apply across Great Britain until 31 December 2023, to ensure British people...

USA – FDA allows sponsors to spread out costs in revised IND charging guidance

The US Food and Drug Administration (FDA) on Monday issued draft guidance providing advice to sponsors about when and how they can charge for...

USA – Legislation could catalyze EU pharma industry innovation

The EU pharmaceutical industry has warned that the bloc is lagging behind when it comes to innovation and losing its position in the global...

Europe – EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU

EMA has recommended granting a marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva for use in the primary vaccination of people from 18 to 50 years...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – Pandemic highlighted challenges of ATMP clinical trials in Europe

A conflict between European regulations governing clinical trials and those governing the use of genetically modified organisms (GMO) was distinctly exposed by the COVID-19...