4 mins
02 Oct 2026
A US discussion paper on how to regulate generative AI-enabled medical devices
The FDA's latest discussion paper offers insight into how generative AI-enabled medical devices could be regulated in the future.
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Life sciences blog
Our life sciences law blog brings you up to date news and views on legal, regulation and policy decisions affecting the life science sector.
Results: 185 items
4 mins
10 Aug 2026
AVT: New guidance arrives as HSSIB launches investigation
Last year, we considered NHS England's growing focus on AI scribes and the question that quickly became central to market access: when does an AI-enabled documentation tool become a regulated medical device?
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2 mins
30 Jun 2026
Incentives for medicines innovation and development in the EU Pharma Package
The EU Pharma Package introduces changes to data and market protection, with new incentives for antimicrobials and repurposed medicines.
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3 mins
25 Jun 2026
Blocking the online sale of fake GLP-1 medicines
The High Court’s decision in Novo Nordisk v BT marks an important development in the use of website blocking injunctions, extending a well-established remedy into the health arena.
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3 mins
22 Jun 2026
Unlocking safe AI adoption in healthcare
The 10 Year Health Plan for England and the Life Sciences Sector Plan commit to the NHS becoming the most AI-enabled healthcare system in the world, acknowledging the need for a modernised regulatory framework.
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4 mins
18 Jun 2026
Addressing medicines shortages in the EU: The Pharma Package and the Critical Medicines Act
Medicines shortages are a persistent concern across Europe, affecting important categories of medicines including antibiotics, insulin, cancer treatments and vaccines.
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2 mins
03 Jun 2026
UK medicines regulator consults on a tailored regulatory framework for rare disease therapies
The MHRA has launched a public consultation on a proposed Rare Disease Therapies Regulatory Framework, marking a significant shift in how therapies for very rare conditions will be developed and authorised in the UK.
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2 mins
18 May 2026
UK clinical trials reforms now in force: What sponsors need to know
In a tight funding market, the ability to generate early clinical data at speed can be an important driver of value.
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3 mins
10 Apr 2026
UK–US pharma and medtech partnership, and enhanced regulatory collaboration
Two recent developments in how the US and the UK work together in the life sciences sector promise significant improvements to trade, as well as greater access to innovative products for UK patients.
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5 mins
26 Mar 2026
Updated social media guidance: What pharmaceutical companies need to know
PMCPA has published revised and expanded guidance on the use of social media by pharmaceutical companies
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2 mins
23 Mar 2026
MHRA consultation: Permanent recognition of CE marked devices?
The MHRA is currently consulting on access for CE marked medical devices to the market in Great Britain (England, Scotland, and Wales) over the longer term.
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2 mins
16 Feb 2026
Changes to branded medicines repayment rates under the Statutory Scheme
Two parallel schemes apply to control the costs of branded medicines to the NHS. These longstanding policy tools aim to ensure that the NHS can obtain the best possible value when purchasing medicines.
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