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FDA issues first recommendations on AI for drug development
The new US Food and Drug Administration (FDA) guidance will enhance credibility of AI models in drug and biological product regulatory submissions.
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Regs & Legs
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NICE makes first-of-a-kind recommendation for hearing loss drug
As a novel formulation, the “groundbreaking drug” is expected to improve the quality of life for young cancer patients with hearing loss.
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How automation and digital technologies will unlock the full potential of advanced therapies
Automation and digital technologies, combined with workforce training and regulatory advancements, hold the key to transforming the production of advanced therapies. Dr Stephen Ward, Executive Director at CGT Catapult, shares how leveraging these innovations can facilitate the delivery of life-changing therapies to patients at scale, opening new possibilities for treating…
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ICH Q6(R1): test criteria and specifications
Dave Elder shares industry thoughts on an ICH Q6(R1) concept paper that aims to revise general principles for uniformity and consistency across ICH Q6 guidelines for test criteria and specifications.
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CHMP recommends novel long-acting HIV treatment
The positive opinion means HIV patients could overcome challenges of taking daily oral regimens, says ViiV Healthcare's Chief Medical Officer.
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Innovative biologic prefilled syringe approved in EU
The new treatment option provides a convenient alternative to currently available vials of the bispecific antibody for EU patients with common vision conditions.
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Legislative milestone for UK clinical trials
The amended regulatory framework will foster clinical trial design innovation and provide UK life sciences with faster trial approvals.
whitepaper
NSF’s quality management maturity (QMM) assessment model
10 December 2024 | By
NSF’s quality management maturity (QMM) assessment model: future-proofing quality and supporting supply chain robustness
webinar
Navigating pharmaceutical environmental monitoring in a changing industry
9 December 2024 | By European Pharmaceutical Review, sponsored by Charles River Laboratories
During this virtual panel, industry experts explore the latest advances in environmental monitoring, discuss key challenges within the sector and approaches that can prevent and mitigate these issues.
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Restoring regulatory excellence “central” to UK life science competitiveness
The Association of the British Pharmaceutical Industry (ABPI) asserts that the recommendations will help generate confidence and predictability in medicine regulation in the UK.
whitepaper
Understanding and Applying Updated FDA Guidance
Understanding and Applying the Updated FDA Guidance: Inspection of Injectable Products for Visible Particulates.
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New mass spectrometry Chapter could “revolutionise” biopharma quality assurance
Launch of the USP general method chapter signals a breakthrough in pharmaceutical drug impurity control, according to biopharma experts.
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Pharma Horizons: Sustainability
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key sustainability developments in the pharmaceutical industry and covers topics including regulation, manufacturing and clinical development.
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The EU AI Act: will regulation drive life science innovation away from Europe?
Mike King, Senior Director, Product & Strategy (Quality, Regulatory, Safety & Detect), Digital Products & Solutions at IQVIA and Alex Denoon, Partner at Bristows Law Firm, explore the challenges of implementing the EU AI Act and the impact of GDPR requirements in life sciences.
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Easing the mental health burden with psychedelic therapies – what’s next for the regulatory and clinical landscape?
In this article, Steffanie Wilson, Vice President and Neuroscience Therapeutic Area Lead, Emmes Group, discusses the future of psychedelic research and highlights the impact of the FDA’s decision on Lykos Therapeutics’ NDA for its MDMA therapy to treat PTSD.
