All Journal articles – Page 10
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JournalNavigating the regulatory landscape for regenerative medicines in Japan
This is the final article in a series of three that critically analyse the differences and similarities between the regulation of advanced therapy medicinal products (ATMPs), also known as regenerative medicines…[1],[2]
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JournalHype over hemp as a veterinary feed additive?
There has been much talk about the positive effects of CBD for human health, and there is some suggestion this could apply to animals. Is this desirable – or even legally feasible? Using Germany as a case study, we examine whether – and under what conditions – CBD could be ...
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JournalSelection and justification of regulatory starting materials
A regulatory starting material (RSM) is the registered point at which drug substance manufacturing under good manufacturing practice (GMP) begins. RSMs are defined, isolated materials that are required to meet the general principles outlined in ICH Q11. This article provides guidance for small molecules in selecting and justifying starting materials from a risk-based perspective.
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JournalRequirements for the good distribution practice of medicinal products
No standardisation or formal educational framework to practice as a Responsible Person (RP) currently exists across EU countries. The current RP educational and work experience requirements in EU member states are discussed. (Note that the study was conducted before the UK left the EU, so it is included here among the EU member states.)
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JournalSubstance-based medical devices: regulatory challenges and prospects
Substance-based medical devices comprise a diverse group of products that are regulated under the Medical Devices Regulation, which is applicable since 26 May 2021. Compared with the previous legal framework, the MDR has introduced several extensive changes to the regulatory framework for medical devices that also impact on the marketing of substance-based medical devices in the EU…
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JournalNonclinical immunogenicity evaluation in toxicology studies of biopharmaceuticals
One of the critical features that determines the clinical efficacy and safety of biotherapeutics, especially therapeutic proteins, is their ability to induce formation of antibodies against themselves. However, the clinical outcome cannot be predicted using the immunogenicity data from nonclinical studies…
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JournalOn the path to adoption of decentralised clinical trials
Decentralised clinical trials (DCTs) offer great potential to improve the clinical trial paradigm, bringing more diversity and less burden to the participants we serve. COVID-19 has driven DCTs, offering greater flexibility to clinical trial patients. More needs to be done to make DCTs a standard option.
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JournalFundamentals of regulatory writing: the document development process
Regulatory writers lead the development of high-quality regulatory documents by working in collaboration with colleagues across multiple functions. Document development is a multistep process with the regulatory writer acting as project leader. This article describes each of the stages of the process and suggests best practices for achieving timely project completion and document delivery
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JournalGene therapy: regional assessment comparison
Axicabtagene ciloleucel (tradename YESCARTA) is an autologous chimeric antigen receptor T-cell (CAR-T) therapy that targets CD19 and is approved for the treatment of aggressive, relapsed or refractory forms of B-cell non-Hodgkins lymphoma (NHL). The active substance is composed of a patient’s cells that have undergone ex vivo modification, which causes ...
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JournalGlobal regulatory frameworks for the development of gene therapy products
Gene therapies have the potential to revolutionise the global healthcare system. Some of these products may offer curative benefits to patients with devastating conditions. This continuing professional development (CPD) supplement provides an overview of the regulatory framework for the development of gene therapy products in key markets.
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JournalEU PIP breast implant withdrawal
The Poly Implant Prothèse (PIP) silicone breast implant failures had a socioeconomic impact at an international level, affecting nearly 400,000 patients in 55 different countries,[1] and resulted in major EU regulatory updates. PIP was a French company founded in 1991 and it produced approximately two million sets of silicone breast ...
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JournalFundamentals of the European devices regulatory framework
In the EU, the development of medical devices is supported by the European Commission Directive (93/42/EEC Medical Devices Directive). To this, the EU has a unique system in dealing with medical devices, iconised as the CE Marking, which provides the right for the products to be commercialised in the EU. This continuing professional development supplement presents the unique system of medical devices that is currently applied in the EU. Additionally, the new regulation of medical devices (EU 2017/745 Medical Device Regulation) is also covered.
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JournalKey steps and considerations of the EU centralised procedure
This continuing professional development article aims to provide some of the background and key steps and considerations when using and navigating the EU centralised procedure for a new marketing authorisation application (MAA).
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JournalEluvia: a drug-eluting stent
Peripheral arterial disease (PAD) affects around 8–12 million people in the US.[1] The strong association with ageing, tobacco smoking, and diabetes means that the prevalence of PAD will continue to increase in the coming years. Although 20–50% of patients with PAD are asymptomatic, they are still at significant risk of ...
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JournalFDA regulatory pathways for medical devices
The regulations, developed as a result of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1938, share a common goal with the pharmaceutical regulations: they both strive to ensure that new medical treatments reach the public as quickly as possible while protecting patients and ensuring that the new treatments have a positive benefit–risk balance. However, they approach this goal in different ways. This continuing professional development supplement explains the fundamentals of the FDA regulatory pathways for medical device manufacturers that wish to bring their products to the US market.