USA – FDA finalizes neurodegenerative disease gene therapy guidance
The US Food and Drug Administration (FDA) last week finalized guidance to assist sponsors developing human gene therapy (GT) products for neurodegenerative diseases. In...
France – Virus de la variole du singe : recommandations pour sécuriser les dons...
Ces recommandations sont détaillées dans une note publiée sur notre site internet, mise à jour en novembre 2016. Elles concernent la collecte de selles pour la...
Europe – EU adopts 10-part workplan to guide the acceleration of clinical trials
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have adopted ten priorities as part of a...
France – HAS : Agrément des Bases de données sur les Médicaments
Conformément à l’article L. 161-38 du Code de la sécurité sociale, la HAS est chargée de l'agrément des bases de données sur les médicaments...
Europe – First gene therapy to treat severe haemophilia A
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Roctavian (valoctocogene roxaparvovec) for the treatment of severe haemophilia A in adults who...
UK – NICE recommends AstraZeneca’s Imfinzi for adults with non-small cell lung cancer
The regulatory approval is specifically for adults whose tumours present a protein called PD-L1 on at least 1% of tumour cells and whose disease...
USA – FDA officials impart lessons learned from quality management maturity pilots
The US Food and Drug Administration’s (FDA) should brief pilot participants ahead of the actual assessments and use a simplified rubric for scoring or...
Europe – European Commission grants AstraZeneca three new approvals
The Imfinzi/ Imjudo approvals authorise the combination to be used for the first line treatment of adult patients with advanced or unresectable hepatocellular carcinoma...
USA – FDA finalizes guidance on REMS format and content
The US Food and Drug Administration (FDA) on Wednesday finalized guidance outlining its expectations for the format and content of a risk evaluation and...
USA – FDA revises ANDA facility correspondence draft guidance
The US Food and Drug Administration (FDA) on Friday revised its draft guidance on submitting pre-submission facility correspondence (PFC) for generic drug applicants seeking...
