Last week’s round-up, 12-16 August 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   MHRA’s no-deal Brexit guidance 12 Aug 2019 Updates to the MHRA’s no-deal Brexit guidance have indicated a shift in the government’s willingness to leave without a deal. The guidances typically started with the following statement, which has now been dropped: “Leaving the EU with a deal remains the […]

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Facilitating early access whilst maintaining quality: Highlights from a recent joint EMA-FDA workshop

By Tessa Fiorini-Cohen   The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) both have schemes to fast-track and support development of medicines which address unmet medical needs. Their underlying aim is to help patients benefit from such therapies as soon as possible. However, due to time constraints and novel situations, […]

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