Modalités de dépôt d'un dossier de demande d'évaluation d'acte professionnel

France – HAS : Monkeypox : la stratégie vaccinale réactive précisée pour les primo-vaccinés...

Sur saisine du ministère chargé de la Santé, la HAS précise la stratégie vaccinale à mettre en œuvre autour d’un cas confirmé de variole...

Europe – Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic

Lessons learned from international collaboration on observational research during the pandemic were highlighted during the latest global regulatory workshop on COVID-19 observational studies and...

Europe – EMA Management Board: highlights of June 2022 meeting

At its 16 June 2022 meeting in Amsterdam, the European Medicines Agency's (EMA) Management Board elected Christelle Ratignier-Carbonneil as vice-Chair of the Board for a three-year...
New guidance on biologics affects authorized generics

USA – FDA authorizes Pfizer, Moderna vaccines for youngest children

The US Food and Drug Administration (FDA) on Friday authorized the emergency use of Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children as young as...

Europe – Start of rolling review for adapted Spikevax COVID-19 vaccine

EMA has started a rolling review for a version of Spikevax adapted to provide better protection against specific variants of SARS-CoV-2, the virus that...

UK – NICE recommends Eli Lilly’s breast cancer therapy

Eli Lilly has announced that Verzenios – also known as abemaciclib – in combination with endocrine therapy, has been recommended by the National Institute...

UK – Genedrive genetic variant test for infants evaluated by NICE

Genedrive – the near patient molecular diagnostics company – has revealed that the National Institute for Health and Care Excellence (NICE) has started an...
MHRA Offers No-Deal Guidance on Pharmaceutical Product Certificates

UK – MHRA joins international partnerships to set global standards for medicines and medical...

The UK is set to play a greater international role in making sure medicines and medical devices are regulated safely and efficiently worldwide, the...

Europe – Start of rolling review for adapted Comirnaty COVID-19 vaccine

EMA has started a rolling review for a version of Comirnaty adapted to provide better protection against a specific variant or variants of SARS-CoV-2,...

Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2022

Update on review of cases of heavy menstrual bleeding with mRNA COVID-19 vaccines The PRAC is continuing its assessment of cases of heavy menstrual bleeding (heavy periods)...

NOS PROCHAINES FORMATIONS