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Industry newsACT EU issues draft guidance on clinical trials during emergencies
Accelerating Clinical Trials in the EU (ACT EU) has issued new draft guidance that outlines clinical trial conduct during public health emergencies (PHEs). Public consultation is open until 30 April 2026.
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Industry newsFDA launches new consolidated adverse event reporting system
The US Food and Drug Administration has introduced a consolidated adverse event database spanning all regulated product categories, from medical products and devices to food, cosmetics and veterinary medicines, aiming to enhance cross-category safety surveillance.
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Industry newsFDA launches framework for accelerating development of individualised therapies for ultra-rare diseases
This industry news explores new FDA draft guidance that considers the use of the plausible mechanism framework to develop individualised medicines where randomised controlled trials are not feasible.
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Industry newsMHRA seeks views on indefinite acceptance of CE-marked medical devices
This industry news update summarises the MHRA proposals for indefinite recognition of CE-marked medical devices in Great Britain and the potential impact for health systems and patients.
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Industry newsNew ICH M15 Guideline sets harmonised framework for MIDD
This industry news update gives details of the ICH M15 adoption and its aim to establish standardised good practice for the use of evidence derived from model-informed drug development.
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Industry newsFDA approves non-invasive device for pancreatic cancer treatment
This industry news update shares details of the FDA’s approval of Optune Pax, a medical device enabling treatment in a home setting.
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Industry newsDIN SPEC 91509: A milestone for structured, digital medical device documentation
This industry news update introduces a new model that will help with the digitalisation of documentation under EU law.
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Industry newsMHRA points to clinical trial growth and faster assessment routes
This industry news update shares how clinical trials have grown over the past year and new regulations coming into effect.
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Industry newsMHRA invites Call for Evidence to assess AI regulation
This industry news update explains the reason for the MHRA’s Call for Evidence for AI regulation and provides guidance.
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Industry newsFDA and EMA publish guiding principles of good AI practice in drug development
This industry news updates shares the ten principles of best practice for AI.
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Industry newsSaudi FDA vision to be a leading regulator includes updating guidance on combination products
This industry news updates shares Saudi FDA’s updated guidance for combination products.
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Industry newsEC proposes regulation to simplify rules on medical and in vitro diagnostic devices
This industry news update shares the EC’saim to simplify medical and IVD device rules through a new proposal.
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Industry newsThe VMD changes how it calculates adverse events incidents for animals
This industry news update shares the VMD’s changes to how it calculates adverse events, which has now taken full effect.
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Industry newsDARWIN EU reaches more than 100 research studies
This industry news update shares a major milestone for DARWIN EU that has reached more than 100 research studies.
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Industry newsEMA launches #ItTakesATeam campaign to address medicine shortages
This industry news update explains the #ItTakesATeam campaign which aims to raise awareness of medicine shortages.
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Industry newsMHRA advances new reform for the treatment of rare diseases
This industry news update explores the MHRA’s upcoming framework that addresses treatments related to rare diseases.
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Industry newsEMA ETF offers scientific advice for antimicrobial resistance
This is an industry news update about the EMA’s ETF that offers scientific advice for antimicrobial resistance.
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Industry newsEMA launches #HealthNotHype campaign
This industry news update shares the EMA’s new social media campaign to raise awareness for GLP-1 medicines.
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Industry newsMHRA cuts approval times for UK clinical trials in half
This industry news update announces the MHRA’s decision to reduce clinical trial approvals from 91 days to 41 days.
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Industry newsNICE reviews health technology assessment to better support patients
This industry news update shares NICE’s plans to review how health technologies are evaluated.