USA – FDA releases guidance on labeling of drug use-related software outputs
The US Food and Drug Administration (FDA) has released draft guidance with considerations on how to include software outputs of drug use-related software in...
Suisse – Swissmedic updates guidance on temporary medicine authorization to harmonize deadlines
The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance on the temporary authorization of human medicinal products.
In the document, Swissmedic outlines the...
USA – FDA guidance on conducting trials during emergencies shifts away from COVID-19
The US Food and Drug Administration (FDA) issued revised final guidance to assist sponsors, investigators, and institutional review boards conducting clinical trials during disasters...
UK – COVID-19: guidance for people whose immune system means they are at higher...
The success of the coronavirus (COVID-19) vaccination programme has meant that the requirement for shielding and identifying people as clinically extremely vulnerable (CEV) is...
UK – NICE recommends more genetic testing for links to ovarian cancer
The National Institute for Health and Care Excellence (NICE) has recommended that more people get tested for genes linked to ovarian cancer.
The new guideline...
USA – FDA expands types of acceptable confirmatory evidence in new guidance
In a new draft guidance, the US Food and Drug Administration (FDA) outlined the types of confirmatory evidence it will accept from sponsors that...
France – Médicaments à base de miansérine : rappel du bon usage et des...
Ces dernières années, des signalements d’usage non conforme de miansérine, dans la prise en charge de troubles du sommeil, chez des patients sans...
USA – Biosimilar labeling guidance suggests cutting interchangeability details from labels
In new draft guidance on biosimilar labeling, the US Food and Drug Administration (FDA) recommends removing details about interchangeability from the labels of these...
UK- Pfizer’s Vydura recommended by NICE for acute migraines
The National Institute for Health and Care Excellence (NICE) has recommended Pfizer’s Vydura (rimegepant) as a cost-effective option for the treatment of acute migraines...
France – La campagne de vaccination contre le Covid-19 avancée au 2 octobre alors...
Face à une augmentation de la circulation du virus responsable du Covid-19, le ministre de la santé, Aurélien Rousseau, a décidé d’avancer la campagne...
