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The US Food and Drug Administration (FDA) on Monday issued draft guidance providing advice to sponsors about when and how they can charge for...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