France – Chimiothérapies par fluoropyrimidines (5-FU) : l’Institut et la HAS actualisent leurs recommandations...
Chaque année en France, près de 80 000 personnes atteintes d’un cancer - principalement digestif, du sein ou ORL - sont traitées par une...
Europe – Regulatory requirements for conditional marketing authorization ‘evolving’
Regulatory requirements for conditional marketing authorizations (CMAs) are “evolving” and more complicated than in the past in terms of demonstrating a product’s major therapeutic...
USA – FDA finalizes electronic postmarketing safety reporting guidance
The US Food and Drug Administration (FDA) has finalized guidance that outlines how postmarketing safety reports for drugs and biologics should be submitted electronically....
Europe – Pandemic highlighted challenges of ATMP clinical trials in Europe
A conflict between European regulations governing clinical trials and those governing the use of genetically modified organisms (GMO) was distinctly exposed by the COVID-19...
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 – Combination products: Non-harmonized regulations are hurting manufacturers
Divergent global regulatory frameworks are making it tough for manufacturers to move ahead with innovative combination drug/device products, according to a panel of experts...
International – E6(R3): ICH releases draft of overhauled GCP guideline for consultation
The International Council for Harmonisation (ICH) on Tuesday published the long-awaited draft version of its ICH E6(R3) guideline on good clinical practice (GCP) for...
International – Un médicament fait espérer l’éradication de la maladie du sommeil
L’éradication de la « maladie du sommeil » – ou trypanosomiase africaine – serait-elle à portée de main ? C’est l’espoir que suscitent les résultats d’un essai...
USA – FDA revises guidance on electronic systems and signatures in clinical trials
The US Food and Drug Administration (FDA) on Wednesday revised its draft guidance on electronic systems, records and signatures in clinical trials. While the...
Europe – ICH Guideline M12 on drug interaction studies
This guideline provides recommendation to promote a consistent approach in designing,
conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies...
