USA – Most FDA warning letters this year from onsite inspections
A US Food and Drug Administration (FDA) official said that most warning letters issued for drug good manufacturing practice (GMP) issues in fiscal year...
Europe – EMA recommends measures to minimise risk of serious side effects with Janus...
EMA’s safety committee (PRAC) has recommended measures to minimise the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat...
USA – Sentinel System expands capacity, data linkages, report indicates
The US Food and Drug Administration’s Sentinel System, which monitors the safety of approved medical products, has expanded its capacity to support regulatory decisions...
International – Pharma groups question enhanced approach in Q14, call for more alignment between...
Pharmaceutical industry groups praised certain aspects of the International Council for Harmonisation (ICH) draft Q14 and Q2(R2) guidelines yet had questions on how enhanced...
Europe – Annex to the European Commission guideline on ‘Excipients in the labelling and...
This document is an annex to the European Commission guideline on Excipients in the labelling and package leaflet of medicinal products for human use.
It contains a list of excipients with a known...
Europe – Monkeypox: EMA starts review for Imvanex
EMA’s human medicines committee (CHMP) has started a review of data to extend the use of the smallpox vaccine Imvanex to include protecting people...
UK – G7 health ministers unite to protect world from another pandemic
Commitments also made on tackling antimicrobial resistance (AMR) – a global killer costing millions of lives a year
Focus on climate and health...
USA – FDA pulls Evusheld authorization as coronavirus evolution quashes another therapy
The evolution of the coronavirus has knocked out another treatment.
The Food and Drug Administration on Thursday withdrew the authorization of Evusheld, the latest antibody therapy to...
USA – Study: Certain cancer drugs saw widespread use before accelerated approval withdrawal
In the period between when three accelerated approval (AA) drugs received approval from the US Food and Drug Administration (FDA) for oncology indications and...
International – ICH guideline Q13 on continuous manufacturing of drug substances and drug products
This guideline applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. It is applicable to CM for new...
