Europe – EMA recommends restricting use of cancer medicine Rubraca
EMA’s human medicines committee, CHMP, has recommended that Rubraca (rucaparib camsylate) should no longer be used as third-line treatment for cancers of the ovary, fallopian...
Europe – EMA recommends approval of Imvanex for the prevention of monkeypox disease
EMA’s human medicines committee (CHMP) has recommended extending the indication of the smallpox vaccine Imvanex to include protecting adults from monkeypox disease.
The medicine has been approved in the EU...
USA – FDA offers new guidance on therapeutic equivalence evaluations
In draft guidance issued on Wednesday, the US Food and Drug Administration (FDA) explains its approach to therapeutic equivalence (TE) evaluations and the assignment...
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The US Food and Drug Administration (FDA) has released draft guidance to assist sponsors with incorporating dose banding information in drug labeling for ready-to-use containers in...
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 – Global regulators call for international collaboration to integrate real-world evidence into regulatory...
EMA has endorsed a joint statement calling for international collaboration to enable the generation and use of real-world evidence for regulatory decision-making published today by the International...
Europe – ICH Guideline M12 on drug interaction studies
This guideline provides recommendation to promote a consistent approach in designing,
conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies...
UK – Easier access to locally-applied HRT to treat postmenopausal vaginal symptoms in landmark...
For the first time ever in the UK, postmenopausal women will be able to access a low dose Hormone Replacement Therapy (HRT) product from...
USA – Industry asks FDA to expand scope of product quality assessment guidance
Stakeholders want the US Food and Drug Administration (FDA) to include biosimilars and other biologics regulated by the Center for Biologics Evaluation and Research...
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...
