USA – Cell therapy equipment: regulatory guidelines and feedback opportunities

Cell therapy manufacturing requires specialized equipment to prioritize cell health, yield, and performance. A range of suppliers offer tailored equipment, but evolving regulatory guidance...

USA – FDA updates early Alzheimer’s drug development guidance to add support for biomarkers,...

The US Food and Drug Administration (FDA) has released a second revision of its draft guidance for developing drugs intended to treat early Alzheimer’s...

Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024

EMA’s safety committee (PRAC) concluded that there was insufficient evidence to establish a causal association between the COVID-19 vaccines Comirnaty and Spikevax and cases of...
Modalités de dépôt d'un dossier de demande d'évaluation d'acte professionnel

France – La HAS actualise la stratégie de vaccination contre le zona

Causé par la réactivation du virus varicelle-zona, le zona est une affection virale de la peau et des muqueuses qui touche particulièrement les personnes...

Europe – DARWIN EU® continues expanding its capacity to deliver real-world data studies

The Data Analysis and Real World Interrogation Network DARWIN EU will continue working towards higher capacity for real-world data (RWD) studies and seeks to...
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) - updated information

Switzerland – Nouvelles autorisations de médicaments complémentaires et de phytomédicaments

Chaque année, un grand nombre de médicaments complémentaires et de phytomédicaments ainsi que de bonbons et pastilles pour la gorge et contre la toux...

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...
Levothyrox : l’ANSM publie les dernières données issues de l’enquête de pharmacovigilance

France – Cannabis médical : point d’étape sur la dernière année de l’expérimentation et...

La fin de l'expérimentation et la mise à disposition pour 2025 des médicaments à base de cannabis se préparent. Ces médicaments devront avoir obtenu...

USA – Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry

This guidance provides recommendations to assist industry and other parties involved in the development of antibody-drug conjugates (ADCs) with a cytotoxic small-molecule drug or...

USA – How to learn about biologics CMC: advice on technical issues, regulatory strategy,...

Chemistry, manufacturing and controls (CMC) are an integral step in creating an effective biological product — and a crucial element of an effective biologics...