USA – Labeling, DTC advertising and compounding rules make FDA’s semiannual regulatory agenda
The US Department of Health and Human Services (HHS) has published its semiannual regulatory agenda that includes rules the Food and Drug Administration (FDA)...
USA – FDA finalizes guidance on drug quality consensus standards recognition program
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday published a final guidance on its process for...
Europe – Paving the way towards coordinated clinical trials in public health emergencies in...
EMA has published a report from a workshop that collected insights and suggestions for possible EU-level actions to improve the way clinical trials are set...
International – WHO proposes best practices for clinical trials
The World Health Organization (WHO) has issued a draft guidance spelling out some of the important scientific and ethical considerations for well-designed clinical trials....
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...
