Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2023
PRAC recommends measures to minimise the risk of serious side effects with medicines containing pseudoephedrine
EMA’s safety committee, PRAC, has recommended new measures for medicines containing...
Europe – EMA confirms its recommendation to update the antigenic composition of authorised COVID-19...
In April 2024, the European Medicines Agency (EMA) issued a recommendation to change the antigenic composition of authorised COVID-19 vaccines for use during the...
Europe – EMA addendum addresses vaccine development for immunocompromised people
The European Medicines Agency (EMA) has published a draft addendum to a guideline on vaccine development that encourages collecting clinical trial data on immunocompromised...
UK – mRESVIA RSV vaccine approved to protect patients aged 60 and over
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an mRNA respiratory syncytial virus (RSV) vaccine (brand name mRESVIA) to protect patients aged...
USA – FDA addresses use of remote interactive evaluations in post-pandemic era
Draft guidance from the US Food and Drug Administration (FDA) outlines the agency’s approach for remote interactive evaluations (RIE) of pharmaceutical and biologics facilities...
Europe – Guideline on clinical investigation of medicinal products in the treatment or prevention...
This guideline intends to address the current EU regulatory position on the main topics of the clinical development of new medicinal products in the...
International – ICH Q12 IWG “Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management »
L'ICH Q12 (IWG) "Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management" Module 8 Training Material est désormais accessible sur le site web de...
UK – Responding to new final draft guidance from NICE for a new gene...
Professor Sir Stephen Powis, NHS National Medical Director, said: “This transformative gene therapy is the first of its kind for haemophilia B patients on...
International – VIH : un médicament préventif efficace, avec deux injections par an seulement,...
C’est un « moment historique » s’est réjoui, mercredi 24 juillet, le professeur Yazdan Yazdanpanah, directeur de l’Agence nationale de recherche sur le sida-maladies infectieuses émergentes. Mais...
