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...
USA – FDA releases guidance on labeling of drug use-related software outputs
The US Food and Drug Administration (FDA) has released draft guidance with considerations on how to include software outputs of drug use-related software in...
Suisse – Swissmedic updates guidance on temporary medicine authorization to harmonize deadlines
The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance on the temporary authorization of human medicinal products.
In the document, Swissmedic outlines the...
USA – FDA guidance on conducting trials during emergencies shifts away from COVID-19
The US Food and Drug Administration (FDA) issued revised final guidance to assist sponsors, investigators, and institutional review boards conducting clinical trials during disasters...
UK – COVID-19: guidance for people whose immune system means they are at higher...
The success of the coronavirus (COVID-19) vaccination programme has meant that the requirement for shielding and identifying people as clinically extremely vulnerable (CEV) is...
