Europe – Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for...
The assessment report of the CHMP’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products provides general guidance...
France – Chimiothérapies par fluoropyrimidines (5-FU) : l’Institut et la HAS actualisent leurs recommandations...
Chaque année en France, près de 80 000 personnes atteintes d’un cancer - principalement digestif, du sein ou ORL - sont traitées par une...
Europe – EFPIA: EU pharma manufacturing would ‘grind to a halt’ under proposed PFAS...
The European Union’s proposed restriction on the use of per- and polyfluoroalkyl substances (PFAS), also known as “forever chemicals,” would have grave implications on...
USA – CBER revises internal procedures for processing clinical holds, NDAs and BLAs
The US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has published two internal policy guides for staff outlining procedures for...
Europe – Euro Roundup: Pharma reform could cause loss of 3 new orphan drugs...
The European Commission’s plan to reform pharmaceutical legislation could cause three fewer rare disease drugs to come to market each year, according to a...
International – The WHO anatomical therapeutic chemical/defined daily dose toolkit
This article provides a high-level overview of the anatomical therapeutic chemical/defined daily dose (ATC/DDD) toolkit developed by the World Health Organization (WHO) for drug...
Switzerland – Swissmedic updates adverse event reporting requirements for 2024
Swissmedic has updated its frequently asked questions (FAQ) page for marketing authorization holders submitting adverse events reports (ADR) as part of the agency’s pharmacovigilance...
UK – Guidance : Drug Safety Update: monthly PDF newsletter
Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor, the Commission on Human Medicines...
UK – NICE nod for Darzalex with lenalidomide and dexamethasone
The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the National Institute for Health and Care Excellence (NICE) has recommended Darzalex –...
USA – FDA guidances keep coming, new device harmonization plan, and more
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical...
