Europe – EMA statement on ongoing review of GLP-1 receptor agonists
EMA’s safety committee, the PRAC, is reviewing data on the risk of suicidal thoughts and thoughts of self-harm with medicines known as GLP-1 receptor agonists,1 including...
USA – FDA describes agency’s initiatives to accommodate growth in cell and gene therapy...
A US Food and Drug Administration (FDA) official discussed the agency’s recent efforts to spur the development of cell and gene therapies during a...
France – Stratégie de vaccination contre la Covid-19 : actualisation des recommandations relatives à...
Les données d’immunogénicité qui montrent à la fois une réponse humorale Covid-19 similaire et une réponse humorale plus faible en cas de coadministration des...
USA – Stakeholders want consistency, more examples in last FDA draft guidance on patient-focused...
The last draft guidance on using clinical outcomes assessments (COA) as endpoints in patient-focused drug development (PFDD) should use terminology more consistently, align more...
UK – Novavax COVID-19 vaccine produces immunity
Researchers leading the University of Oxford’s Com-COV3 study have delivered results from a study researching the immune response and side-effect profile of ‘mixed’ two-dose...
Europe – Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for...
The assessment report of the CHMP’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products provides general guidance...
Europe – Clinical Trials Information System (CTIS) – Sponsor Handbook
The aim of the EMA CTIS Sponsor Handbook (‘Handbook’) is to provide clinical trial (CT) sponsors representing pharmaceutical industry, SME (small and medium-sized enterprises),...
Australia – Nitrosamine risk assessment in Category 1 prescription medicine registration applications
Sponsors need to be aware of the global issue relating to nitrosamine impurities in medicines. In particular, they should be familiar with the known...
International – ICH paper calls for ‘stepwise’ harmonization of RWE
The International Council for Harmonisation (ICH) issued a Reflection Paper outlining a “stepwise” approach to harmonization of real-world data and evidence (RWD/RWE) that includes...
Europe – Phasing out of extraordinary COVID-19 regulatory flexibilities
EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the extraordinary regulatory flexibilities for medicines put in place during the COVID-19...
