Exciting but uncertain times for medtech regulation
This article was originally published in Clinica
Jeffrey Shuren really shouldn't have implied that the regulatory system for medical devices in the EU allowed patients to be used as guinea pigs. But that's just what the head of the US Food and Drug Administration's device centre did. Dr Shuren then also went on to argue that – despite there being "some very basic differences between the two systems that confound comparisons" – the US system was more robust than the EU system in ensuring that patients receive safe and effective products.
You may also be interested in...
The Pink Sheet explains the procedures underpinning the UK’s emergency use authorization of the Pfizer/BioNTech COVID-19 vaccine.
The European public assessment report for Novartis's advanced breast cancer therapy, Piqray (alpelisib), includes some interesting insights into what EU regulators are looking for in drug company clinical trials.
A lower first dose boosted the vaccine’s efficacy result, but AstraZeneca has conceded that this has to be proven in a separate trial. In the meantime, the UK government has asked the regulator to assess the vaccine under a special health emergency provision.