Europe – Review: real-world data studies
Sustainable framework to support scientific evaluations in the EU
By complementing existing evidence, use of real-world data (RWD) and real-world evidence (RWE) can speed up...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
14 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its July 2023 meeting.
The CHMP recommended granting a marketing authorisation for Abrysvo (bivalent, recombinant),...
Europe – First RSV vaccine to protect infants up to 6 months of age...
EMA has recommended granting a marketing authorisation in the European Union (EU) for Abrysvo, a vaccine to protect against disease caused by the respiratory syncytial virus (RSV)....
Europe – Reflection paper on the use of artificial intelligence in the lifecycle of...
EMA has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation...
France – Traitement de l’acné sévère : mieux faire connaître les risques associés à...
Pour renforcer l’information sur les effets indésirables liés à l’isotrétinoïne orale et les précautions à adopter en cas de traitement, un dossier thématique est...
International – WHO seeks to align biowaiver policy with ICH guidelines
The World Health Organization (WHO) wants to align its bioequivalence classifications with other global guidelines by reducing the number of in vivo studies required to prove...
USA – FDA issues draft guidance on reporting manufacturing changes for gene therapies
The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Friday issued a guidance to assist sponsors of cell...
USA – FDA Approves New Drug to Prevent RSV in Babies and Toddlers
Today, the U.S. Food and Drug Administration approved Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates...
USA – FDA revises IEM drug draft guidance to clarify food standards, use of...
The US Food and Drug Administration (FDA) has issued a revised draft guidance on developing drugs to treat inborn errors of metabolism (IEM) to...
Europe – European Health Union: EU steps up action to prevent shortages of antibiotics...
The European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency are today issuing recommendations for actions to avoid shortages of key antibiotics...
