Europe – Facilitating Decentralised Clinical Trials in the EU
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the conduct of decentralised clinical trials (DCTs)...
USA – FDA revises guidance on responding to ANDA complete response letters
The US Food and Drug Administration (FDA) has revised its guidance on timeframes for responding to complete response letters (CRL) to abbreviated new drug...
USA – FDA issues draft guidance on pulmonary tuberculosis drugs
The US Food and Drug Administration (FDA) has released new draft guidance on developing drugs for pulmonary tuberculosis.
FDA’s latest draft guidance is intended to...
Europe – EMA recommendation paper: Safety, data integrity key to decentralized trial conduct
The European Medicines Agency (EMA), European Commission (EC), and Heads of Medicines Agencies (HMA) recently acknowledged the growing role of decentralized elements in the...
Europe – First gene therapy to treat haemophilia B
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Hemgenix (etranacogene dezaparvovec) for the treatment of severe and moderately severe haemophilia...
USA – Experts: Give FDA authority to remove ineffective drugs
The FDA is struggling to remove drugs from the marketplace that don’t show effectiveness in late stage trials, new JAMA analyses found, thanks to...
USA – NIH aims to reduce reputation bias in grant reviews
The US National Institutes of Health (NIH) has released a tentative plan to change how its research grant applications are scored, with the aim of reducing...
France – Pénurie d’amoxicilline : les recommandations de l’ANSM pour une utilisation rationnelle
Depuis plusieurs semaines, d'importantes perturbations sont observées sur le marché international des spécialités orales à base d'amoxicilline seule (CLAMOXYL et génériques) ou associée avec l'acide clavulanique...
International – Efficacité et tolérance des vaccins contre la COVID‐19
Nous avons inclus et analysé 41 ECR évaluant 12 vaccins différents, y compris les schémas vaccinaux homologues et hétérologues et l'effet des doses de...
USA – Industry asks FDA to harmonize pediatric study pharmacology guidance with ICH
Industry groups have asked the US Food and Drug Administration (FDA) to align its recently re-drafted guidance on pediatric clinical pharmacology studies with international...
