MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – MHRA safety review of medicines containing pseudoephedrine

Pseudoephedrine is used for the symptomatic relief of coughs, colds and allergies. Pseudoephedrine has been used in the UK for decades in millions and...

International – Industry groups call for changes in ICH M11 guideline on harmonized protocols

In comments to the US Food and Drug Administration (FDA), pharmaceutical industry groups called for revisions to the International Council for Harmonisation’s (ICH) M11...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – European Commission grants AstraZeneca three new approvals

The Imfinzi/ Imjudo approvals authorise the combination to be used for the first line treatment of adult patients with advanced or unresectable hepatocellular carcinoma...

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