FDA Unveils 5 Guidances on Broadening Cancer Clinical Trial Eligibility

USA – FDA Unveils 5 Guidances on Broadening Cancer Clinical Trial Eligibility

As part of a push to transform clinical trial eligibility criteria that have been accepted over time without a clear scientific or clinical rationale,...
MHRA Guidance on a No-Deal Brexit

UK – Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master...

Leaving the EU with a deal remains the government’s top priority. This has not changed. However a responsible government must plan for every eventuality, including a no...
China may launch trials on new gene-editing technology within 2 years

China – China may launch trials on new gene-editing technology within 2 years

China could be just over a year away from clinical trials of a new gene-editing therapy with an unprecedented high level of safety, according...
Les produits cosmétiques non rincés contenant du phénoxyéthanol ne doivent pas être utilisés sur les fesses des enfants de 3 ans ou moins

France – Nouvelle mesure d’accès à l’innovation : ATU de cohorte d’extension d’indication pour...

L'ANSM met en œuvre le nouveau dispositif en faveur d’un accès rapide et anticipé aux traitements innovants. Elle vient en effet d’octroyer la première...
NICE u-turn backs use of Darzalex combo for myeloma relapse

UK – NICE u-turn backs use of Darzalex combo for myeloma relapse

The National Institute for Health and Care Excellence is now backing NHS use of Janssen’s Darzalex plus Velcade and dexamethasone (DVd) after first relapse...
UK’s MHRA Offers 6 New No-Deal Brexit Guidances on Importing, Exporting Medicines

UK – UK’s MHRA Offers 6 New No-Deal Brexit Guidances on Importing, Exporting Medicines

With the possibility of a no-deal Brexit still looming, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday released six new guidance...
EMA Management Board: highlights of March 2019 meeting

Europe – EMA now operating from Amsterdam

As of today, EMA is operating from Amsterdam. EMA left its London premises on 1 March, and following a transitional week of teleworking, its...
NICE nod for Almirall's Ilumetri, UCB's Cimzia

UK – NICE nod for Almirall’s Ilumetri, UCB’s Cimzia

Initially NICE rejected Illumetri for not being cost-effective, but a new negotiated price submitted by the company means that it can now be offered...
Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials

Europe – Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials

1. INTRODUCTION AND SCOPE This document provides recommendations for sponsors regarding the authorisation and conduct of complex clinical trials. The document describes the current perspective...
NICE updates high blood pressure guidelines

UK – NICE updates high blood pressure guidelines

The new plans are in keeping with the NHS Long Term Plan, hoping to improve outcomes in cardiovascular disease (CVD), including preventing strokes and...

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