Europe – New Quality Innovation Expert Group (QIG) supports medicine innovation
EMA has established a Quality Innovation Expert Group (QIG) to support innovative approaches for the development, manufacture, and quality control of medicines for the benefit of...
Europe – EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
EMA’s safety committee (PRAC) has confirmed its recommendation to withdraw the marketing authorisations for amfepramone obesity medicines. This follows a re-examination of its previous recommendation of June 2022, which was...
France – Le logiciel officinal Pharmony One obtient l’agrément Sesam-Vitale
Pharmony One, solution de gestion d'officine en mode SaaS (software as a service, logiciel en tant que service) a décroché l'agrément Sesam-Vitale Addendum 8,...
Europe – 11th edition of the European Pharmacopoeia now available in print
The 11th Edition of the European Pharmacopoeia (Ph. Eur.) is now available in print version.
This latest edition contains numerous revised and new texts, reflecting...
USA – FDA guidance targets dose banding information in drug labels
The US Food and Drug Administration (FDA) has released draft guidance to assist sponsors with incorporating dose banding information in drug labeling for ready-to-use containers in...
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USA – FDA revises ANDA facility correspondence draft guidance
The US Food and Drug Administration (FDA) on Friday revised its draft guidance on submitting pre-submission facility correspondence (PFC) for generic drug applicants seeking...
Europe – Single-arm trials as pivotal evidence for the authorisation of medicines in the...
EMA has opened a public consultation on a reflection paper that discusses key concepts for single-arm clinical trials that are submitted as pivotal evidence in support of marketing authorisation...
