UK – MHRA authorises enzyme inhibitor Anastrozole to prevent breast cancer in post-menopausal women
The Medicines and Healthcare products Regulatory Agency (MHRA) has today authorised this new indication for Anastrozole, a hormone treatment used for breast cancer in...
Europe – EU issues long-awaited GMP Annex 1 revision
The EU’s eagerly anticipated revision of its good manufacturing practice (GMP) Annex 1 for sterile drug products was released on Thursday after 14 years...
International – ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from...
This guideline concerns the testing and evaluation of the viral safety of biotechnology products, and it outlines what data should be submitted in marketing...
USA – mRNA technology for universal flu vaccine shows early promise in US study
The World Health Organization cites vaccination as the current principal means of reducing or counteracting influenza mortality and morbidity burden, but the constantly evolving...
France – Accès précoce et compassionnel: les deux nouveaux référentiels de la Cnil attendus...
PARIS (TICpharma) - La Commission nationale de l'informatique et des libertés (Cnil) a reporté à septembre l'adoption définitive de deux nouveaux référentiels relatifs aux...
USA – Legislation could catalyze EU pharma industry innovation
The EU pharmaceutical industry has warned that the bloc is lagging behind when it comes to innovation and losing its position in the global...
Europe – EMA medical terms simplifier
This compilation gives plain-language descriptions of medical terms commonly used in information about medicines. Communication specialists at EMA use these descriptions for materials prepared...
International – ICH advances guidelines on selective reporting of safety data, viral safety
The International Council for Harmonisation (ICH) recently announced the adoption of its E19 guideline, which outlines a risk-based approach for collecting safety data for...
USA – FDA proposes long-awaited patient medication information rule
The US Food and Drug Administration (FDA) has proposed new drug labeling requirements to make it easier for patients to understand their medication while...
USA – FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults
Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment...
