Tower Mains Weekly Newsletter
Company Updates
Short Guide on Clinical QMS
A Quality Management System (QMS) is a structured framework implemented to manage and maintain an organisation’s quality objectives and expectations. It is pivotal in ensuring participant safety, data integrity, and compliance with regulatory standards. Our Senior Associate, Rita Silvestre has created a short guide introducing the fundamentals of QMS, focusing on its application in clinical settings. To view, click here.
Regulatory Updates
MHRA guidance updates
- Software and Artificial Intelligence (AI) as a medical device. On 3rd May, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the digital mental health technology section in its information for manufacturers, healthcare professionals, researchers, and patients on Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD). Click to view source
FDA guidance updates
- Enforcement policy for certain in vitro diagnostic devices for immediate public health response in the absence of a declaration under section 564. On 6th May, the US Food and Drug Administration (FDA) added draft guidance to describe its enforcement policy for certain laboratory manufacturers offering certain unauthorised in vitro diagnostic devices for immediate response to chemical, biological, radiological, or nuclear agents in the absence of a declaration applicable to IVDs under section 564 of the Federal Food, Drug, and Cosmetic Act. Click to view source
- CVM GFI #290 (VICH GL61) – Pharmaceutical Development. On 6th May, draft guidance was added to describe the suggested contents for the Pharmaceutical Development section for veterinary medicinal products. It provides an opportunity to present the knowledge gained through applying scientific approaches and quality risk management to the development of a product and its manufacturing process. Click to view source
- REMS Logic Model: A framework to link program design with assessment. On 7th May, the FDA published draft guidance describing the agency’s Risk Evaluation and Mitigation Strategy (REMS) logic model. The REMS logic model is a framework that the FDA recommends, which provides applicants with a systematic, structured approach to the design, implementation, and evaluation of a REMS. The aim of applying the REMS logic model is to develop clear goals, objectives, and strategies that align with the intended outcomes and to help applicants of New Drug Applications (NDAs), Biologics License Applications (BLAs), and Abbreviated New Drug Applications (ANDAs) incorporate REMS assessment planning into the design of a REMS. Click to view source
OECD updates AI Principles amidst rapid technological developments
On 3rd May, the Organisation for Economic Co-operation and Development (OECD) announced it has adopted revisions to the landmark OECD Principles on AI. In response to recent developments in AI technologies, notably the emergence of general-purpose and generative AI, the updated Principles more directly address AI-associated challenges involving privacy, intellectual property rights, safety, and information integrity.
Industry Updates
New cabotegravir formulations approved to help prevent HIV-1 infection in adults and adolescents
On 3rd May, the MHRA announced the approval of two new formulations of the medicine cabotegravir (Apretude 30 mg film-coated tablets and Apretude 600 mg prolonged-release suspension for injection) to help prevent sexually transmitted HIV-1 infection in adults and adolescents weighing at least 35kg who are at an increased risk of infection.
FDA announces webinar discussing the final rule “Medical Devices; Laboratory Developed Tests”
On 6th May, the FDA announced a webinar that will be held on Tuesday, 14th May 2024, from 1-2pm (ET) to discuss the final rule “Medical Devices; Laboratory Developed Tests” (LDTs). During the webinar, the FDA will provide an overview of the final rule amending the FDA’s regulations to make it explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory and describe the phaseout of the FDA’s general enforcement discretion approach for LDTs.
Gossamer and Chiesi Group announce collaboration to develop drug to treat respiratory diseases
On 6th May, Gossamer Bio, Inc., a clinical-stage biopharmaceutical company, and Chiesi Farmaceutici S.p.A, an international, research-focused biopharmaceutical group, announced a global partnership and license agreement to develop and commercialise seralutinib. This partnership combines the strengths of both Chiesi and Gossamer to support ongoing work in pulmonary arterial hypertension (PAH) and to accelerate development in pulmonary hypertension associated with interstitial lung disease (PH-ILD), enabling the expansion of the seralutinib franchise to reach more patients with pulmonary hypertension worldwide.
NHS to roll out fibre optic laser therapy to prevent epileptic seizures
On 6th May, NHS England announced it will roll out a new laser beam therapy next month to help reduce seizures for patients with epilepsy. The cutting-edge fibre optic laser therapy, known as Laser Interstitial Thermal Therapy (LITT), targets the part of the brain causing seizures without the need for invasive surgery. The treatment will be rolled out for eligible patients across England from June, being offered at King’s College Hospital in London and The Walton Centre in Liverpool as specialist national hubs.
One Health: A Joint Framework for action published by five EU agencies
On 7th May the European Centre for Disease Prevention and Control (ECDC), the European Chemicals Agency (ECHA), the European Environment Agency (EEA), the European Food Safety Authority (EFSA), and the European Medicines Agency (EMA) published a joint framework for action to strengthen cooperation to support the implementation of the One Health agenda in the EU. The joint framework will be implemented over the next three years (2024-2026), focusing on five strategic objectives: strategic coordination, research coordination, capacity building, stakeholder engagement and joint inter-agency activities. This will ensure that the scientific advice provided by the agencies is increasingly integrated, that the evidence base for One Health is strengthened and that the agencies can contribute with a common voice to the One Health agenda in the EU.
Broken String Biosciences and Francis Crick Institute partner for ALS research
On 7th May, Broken String Biosciences, a genomics company driving the development of the next generation of more precise, safe, and effective cell and gene therapies, announced a research collaboration with the Francis Crick Institute, a world-leading biomedical discovery institute dedicated to understanding the biology underlying health and disease. The project aims to develop novel applications for Broken String’s proprietary DNA break-mapping platform, INDUCE-seq™, beyond its established capabilities in gene editing. The research will be focused on leveraging the technology to investigate the impact of genomic instability in the development of amyotrophic lateral sclerosis (ALS)
Update on initiative on regulation and evaluation of digital mental health technologies
On 7th May, the MHRA released an update on its partnership with the National Institute for Health and Care Excellence (NICE); a partnership aimed at addressing key challenges for regulating and evaluating digital mental health technologies (DMHTs) with input from patients, the public and mental health professionals. The long-term objective of this three-year project, which began in 2023, is to formulate guidance and other sources of information for developers, healthcare professionals, patients and the public to clarify the regulatory and evaluation requirements for DMHTs. Key findings have included the development of a conceptual framework for categorising DMHTs, considerations for regulation and evaluation informed by literature and stakeholder insights and clearer proposals for how DMHTs qualify as Software as a Medical Device (SaMD).
Issue Number: WN00161
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