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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.
The positive opinion means HIV patients could overcome challenges of taking daily oral regimens, says ViiV Healthcare's Chief Medical Officer.
The new treatment option provides a convenient alternative to currently available vials of the bispecific antibody for EU patients with common vision conditions.
The amended regulatory framework will foster clinical trial design innovation and provide UK life sciences with faster trial approvals.
10 December 2024 | By
NSF’s quality management maturity (QMM) assessment model: future-proofing quality and supporting supply chain robustness
9 December 2024 | By European Pharmaceutical Review
During this virtual panel, industry experts will explore the latest advances in environmental monitoring, discuss key challenges within the sector and approaches that can prevent and mitigate these issues.
The Association of the British Pharmaceutical Industry (ABPI) asserts that the recommendations will help generate confidence and predictability in medicine regulation in the UK.
Understanding and Applying the Updated FDA Guidance: Inspection of Injectable Products for Visible Particulates.
Launch of the USP general method chapter signals a breakthrough in pharmaceutical drug impurity control, according to biopharma experts.
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.
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.
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.
European Pharmaceutical Review Issue 5 includes articles on bioprocessing, biologics, sustainability, and drug formulation.
Regulatory inspections can be challenging, but proper preparation turns them into opportunities for improvement and compliance demonstration.
With its novel approach for addressing a fundamental cause of eosinophilic esophagitis, approval of the biologic marks a potential new standard of care for paediatric patients.
