‘No Turning Back’ On Regulatory Changes at UK MHRA
Industry’s Role Praised By Innovation Minister
The UK medicines regulator has a “unique opportunity” to evaluate the systems it operates and to “do things differently", according to its long-term interim head, June Raine.
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Ex-FDA commissioner offers British platform trials as examples of research done right, as he worries about studies that aren’t going to yield ‘definitive information’ crowding out trials that are more compelling and for more promising COVID-19 therapeutics.
A “powerful new vision” for the post-Brexit UK regulatory framework was unveiled at a conference organized by the BioIndustry Association and the medicines regulator, the MHRA.
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.