As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – European Parliament committee proposes changes to pharma legislation

The European Parliament’s health committee is set to debate and vote on changes to the proposed pharmaceutical legislation on 19 March, including provisions that...

USA – FDA offers guidance on minor label changes for OTC drugs

The US Food and Drug Administration (FDA) has clarified definitions and appropriate reporting of minor label changes for over-the-counter (OTC) drugs in draft guidance...
Trois nouvelles guidances du MDCG en Mars 2020

Europe – EU regulators and industry clash on pharmaceutical reform package

European Union officials said a proposal to reform the EU pharmaceutical legislation will go a long way towards providing equal access to new medicines,...

Europe – Commission proposes new measures for the better lifecycle management of medicine authorisations

The Commission has proposed to amend the variation legislation for medicines, to make the lifecycle management of medicines more efficient and better adapted to the...

USA – FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty...

Today, the U.S. Food and Drug Administration approved Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced...

USA – FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain...

FDA approved Jubbonti (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Prolia (denosumab), and Wyost (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Xgeva...

Europe – Procedural advice for orphan medicinal product designation

The legislation on orphan medicinal products, Regulation (EC) No 141/2000 of the European Parliament and of the Council, was adopted on 16 December 1999...

France – Forfait innovation : une 1ère technologie de santé inscrite au remboursement par...

Mis en place en 2009 et piloté par le ministère chargé de la santé, le forfait innovation est un dispositif dérogatoire et temporaire de...

Europe – European Commission proposes framework for joint clinical assessments

The European Commission has proposed a framework for joint clinical assessments (JCA) as part of its effort to implement the EU health technology assessment...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – UK’s MHRA approves first drug under international recognition procedure

The UK Medicines and Healthcare products Regulatory Agency (MHRA) recently approved Amgen’s bone cancer drug Xgeva (denosumab), the first drug submitted through the international...