France – Bronchiolite : Moderna annonce des résultats positifs pour son vaccin
« Le Covid a été un formidable accélérateur pour démontrer la puissance de l’ARN messager, mais nous ne sommes pas qu’une biotech du Covid », confiait...
International – WHO warns on contaminated cough syrups linked to child deaths
This WHO Medical Product Alert refers to two substandard (contaminated) products, identified in Uzbekistan and reported to WHO on 22 December 2022. Substandard medical...
USA – FDA details approach for finding optimal dosages for new cancer drugs
The US Food and Drug Administration (FDA) has issued a draft guidance to help sponsors identify the optimal dosage for cancer drugs in clinical...
USA – FDA and CDC investigate potential safety concern for Pfizer/BioNTech’s COVID-19 vaccine
The investigation was prompted by preliminary data from the CDC’s vaccine safety monitoring system, which raised a question of whether people aged 65 years...
UK – NICE recommends wider use of statins to cut risk of heart attack...
Up until now, NICE has recommended that those with a 10% or higher risk over ten years of a cardiovascular event should be offered...
USA – Omnibus brings new advanced manufacturing programs to FDA
The recently enacted ominous spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to establish advanced manufacturing...
USA – CERSI Summit: Wider use of real-world evidence continues to face hurdles
The widespread use of real-world evidence (RWE) in regulatory decisions continues to face challenges, including problems with data quality and methodologies, and a disconnect...
USA – FDA issues draft guidance on dosage and administration labeling
The US Food and Drug Administration (FDA) has issued draft guidance aimed at improving the consistency of information in the dosage and administration section...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 – 12...
Alignment of dose recommendations for Janus kinase (JAK) inhibitors in patients with certain risk factors
EMA’s safety committee, PRAC has further reviewed measures to minimise the risk of serious...
International – ICH guideline M10 on bioanalytical method validation and study sample analysis –...
In response to questions posted to ICH M10 comment period, a number of Questions and Answers have been devised to provide clarity around some...
