Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices

USA – Rare diseases, STAR expansion considered in PDUFA VII premarket negotiations

Newly released minutes from meetings between industry and the US Food and Drug Administration (FDA) give observers more insight into premarket review issues in...

Europe – CureVac outlines COVID-19 vaccine production plans ahead of regulatory approval

CureVac CEO Franz-Werner Haas told CNBC last week that the company is planning for approval in the EU in the second quarter, depending on the...

USA – FDA: Master protocols have value in COVID-19, and beyond

An official from the US Food and Drug Administration (FDA) recommended that developers of COVID-19 drugs consider using master protocols to assess the benefits...

Europe – Euro Roundup

Big pharma trade group EFPIA has called on the European Commission to create a multi-stakeholder forum to discuss how to improve access to medicines....

Europe – Changing the labelling and package leaflet (Article 61(3) notifications) : Update

This page lists questions that marketing-authorisation holders (MAHs) may have on Article-61(3) notifications. It provides an overview of the European Medicines Agency's position on...

Europe – COVID-19 vaccine safety update : Janssen-Cilag International NV

PRAC started an assessment of embolic and thrombotic events (blood clots obstructing blood vessels), following a small number of reported cases of suspected serious,...

Europe – COVID-19 vaccine safety update : COMIRNATY BioNTech Manufacturing GmbH

Based on data from clinical trials and use in vaccination campaigns, PRAC requested the addition of the following hypersensitivity reactions (allergic reactions) to the...

Europe – COVID-19 vaccine safety update : VAXZEVRIA AstraZeneca AB

PRAC continued its assessment of cases of embolic and thrombotic events (blood clots obstructing blood vessels) reported for Vaxzevria from its use in vaccination...

UK – NICE recommends Alexion’s PNH treatment Ultomiris

Specifically, NICE has backed the use of Ultomiris (ravulizumab) in the NHS for the treatment of PNH in adult patients with haemolysis and clinical...

Europe – EMA starts review of VIR-7831 for treating patients with COVID-19

EMA is reviewing currently available data on the use of the monoclonal antibody VIR-7831 (also known as GSK4182136) in the treatment of patients with...

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