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【EXPERT Q&A】How to build the quality management system of aseptic IVD for medical devices?

Drugdu.com expert’s response: The establishment of a quality management system (QMS) for sterile in vitro diagnostic (IVD) medical devices is a complex and systematic process aimed at ensuring product safety, effectiveness, and compliance with regulatory requirements. Below is a detailed, professional step-by-step approach, referencing the Medical Device Manufacturing Practice and relevant regulatory mandates: I. Define Quality Policy and Objectives 1.Establish Quality Policy: The enterprise shall articulate a quality policy that embodies its commitment to medical device quality and patient safety. 2.Set Quality Objectives: Based on the quality policy, set specific, measurable quality objectives, such as product conformity rates and customer satisfaction levels. II. Establish Organizational Structure and Responsibilities 1.Setup Management Organization: Create a management structure tailored to medical device production, clearly defining the responsibilities and authorities of each department. 2.Appoint Management Representative: The corporate leader should designate a management representative responsible for establishing, implementing, and maintaining the QMS. 3.Clarify Responsibilities and Authorities: ...
- Source: drugdu
- 80
- July 31, 2024
Silicon Chip Based Blood Test Rapidly Diagnoses Patients with Hypothyroidism

Hypothyroidism impacts about 10% of the U.S. population, making the Thyroid Stimulating Hormone (TSH) test the most frequently conducted immunoassay in the United States. Traditional testing often involves significant time commitments for patients, including visits to labs and waiting 2 to 5 days for results. Now, a new TSH immunoassay performed on a silicon chip delivers results in approximately 30 minutes. Genalyte (San Diego, CA, USA) has received U.S. Food and Drug Administration (FDA) approval for its groundbreaking immunoassay, the first of its kind to be cleared for use on a silicon chip-based device. The Maverick Diagnostic System (MDS) incorporates silicon chip-based photonic ring resonator technology, enabling the execution of multiple rapid tests simultaneously from a small sample of whole blood or serum. This system is also connected to the cloud, facilitating the retrieval of assay protocols and enabling clinical oversight. Genalyte’s innovation effectively minimizes the traditional bulky lab machinery ...
- Source: drugdu
- 100
- July 31, 2024
Study reveals blood proteins predict risk of developing many diverse diseases

Researchers predicted the onset of 67 diseases, out-performing current standard models A study conducted in partnership between University College London (UCL), GSK, Queen Mary University of London, Cambridge University and the Berlin Institute of Health at Charité Universitätsmedizin, Germany, has revealed that proteins in the blood could predict the onset of many diverse diseases. The findings published in Nature Medicine could offer new prediction possibilities to treat and diagnose a wide range of diseases, including multiple myeloma, non-Hodgkin lymphoma, motor neurone disease, pulmonary fibrosis and dilated cardiomyopathy. Utilising the UK Biobank Pharma Proteomics Project, researchers used data linked to electronic health records of 3,000 plasma proteins from a randomly selected set of over 40,000 participants. Using advanced analytical techniques to measure thousands of proteins in a single drop of blood, researchers pinpointed each disease between the five and 20 proteins most important for prediction to predict the onset of 67 ...
- Source: drugdu
- 73
- July 31, 2024
New gut microbiome atlas could offer better treatment for digestive disorders

The new Human Gut Microbiome Atlas could help treat conditions including IBS and AMR Researchers from King’s College London (KCL) have developed a new gut microbiome atlas in collaboration with MetaGenoPolis and the Science for Life Laboratory to help better understand how microorganisms in the gut impact disease. Published in Genome Research, the Human Gut Microbiome Atlas, which identifies gut bacteria in people with 23 separate diseases across 19 countries, could lead to more effective treatments for conditions such as inflammatory bowel disease (IBS). The human gut microbiome provides an individual profile of bacteria and other microorganisms that live in the gut, which helps perform key bodily functions, including digestion. However, fragmented data existing on the genetic makeup of individual microbes in the gut has prevented large-scale comparative studies and doctors from tailoring treatment to work with the specific microbiome of patients. After performing a survey of genetic data from ...
- Source: drugdu
- 72
- July 31, 2024
CHMP backs Boehringer’s Spevigo for preventing rare psoriasis flare-ups

The European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a new indication of Boehringer Ingelheim’s Spevigo (spesolimab) injection for the prevention of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age. Spevigo originally received a European Commission approval for the infusion in December 2022, for the treatment of GPP flares in adults as a monotherapy. However, this approval would offer younger patients the chance to use Spevigo to prevent flare-ups. Spevigo attaches to the interleukin-36 receptor (IL-36), which plays a crucial role in the immune system’s signalling pathway and is implicated in the pathogenesis of GPP. GPP is a rare, severe type of psoriasis where patients suffer from widespread pustules on red skin, often accompanied by systemic symptoms like fever and fatigue. It is distinct from other forms of psoriasis, as it can become life-threatening due to complications ...
- Source: drugdu
- 92
- July 31, 2024
SINOPHARM and University of Macao Joint Laboratory Project Signing Completed

On July 19, 2024, the Matchmaking Meeting and Signing Ceremony of Macao-Qin Science and Technology Industry, Academia and Research Capital was held in Hengqin Guangdong-Macao Deep Cooperation Zone (hereinafter referred to as the “Zone”). For the first time, the event brought together representatives from Macao’s universities, high-quality enterprises and industrial capital to build a high-level platform for matching and exchanges between industry, academia, research and capital. At the scene of the event, 4 Macao universities signed contracts with 16 well-known enterprises and organizations in the industry. Among them, the cooperation between SINOPHARM and the University of Macau Joint Laboratory Project completed the signing. Secretary for Economy and Finance of the Macao Special Administrative Region and Director of the Executive Committee of the Zone, Mr. Li Weinong attended the event and delivered a speech. Xu Jian, Vice President of the University of Macau, Chen Guokai, President of the Institute of Science ...
- Source: drugdu
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- July 31, 2024
in-PHARMA JAPAN

Organiser：Reed Exhibitions Time：July 9 – July 11, 2025 address： 3-21-1 Ariake, Koto-ku, Tokyo 135-0063, Japan Exhibition hall：Tokyo Big Sight International Exhibition Center Product range: Pharmaceutical Raw Materials and Ingredients: Pharmaceutical raw materials, Active Pharmaceutical Ingredients (API), intermediates, additives, functional raw materials, natural extracts, fine chemicals, business outsourcing/contract manufacturing/OEM, formulations, various analytical services and analytical equipment, as well as other raw materials, related services, and technologies. Pharmaceutical Machinery and Equipment: Packaging equipment/materials, containers, material processing equipment, sterilization and cleanroom equipment, process inspection/testing equipment, laboratory measurement/analysis equipment, pure water production/control equipment, supply and conveyor equipment, equipment engineering, pumps and valves, IT solutions, logistics services, etc. Biopharmaceuticals: Laboratory equipment/reagents, biologics, drug discovery, biotechnology, genomics, etc. About in-PHARMA JAPAN： in-PHARMA JAPAN is Japan’s leading B2B trade exhibition for pharmaceutical raw materials and ingredients. It attracts a large number of domestic and international pharmaceutical companies to visit, inspect, and actively engage in material selection ...
- Source: drugdu
- 115
- July 31, 2024
FDA Approves Alpha Cognition’s Zunveyl as Oral Therapy for Mild-to-Moderate Alzheimer Disease

July 29, 2024 By Don Tracy, Associate Editor Approval of Zunveyl offers a novel approach with a dual mechanism of action designed to improve tolerability and efficacy in treating Alzheimer disease, company says.The FDA has approved Alpha Cognition’s Zunveyl (benzgalantamine), an oral therapy for treating mild-to-moderate Alzheimer disease (AD). According to the company, the approval marks a significant advancement in the treatment of AD by offering a novel approach with a dual mechanism of action designed to improve tolerability and efficacy. Zunveyl is a prodrug of galantamine, an acetylcholinesterase inhibitor (AChEI), that works by preventing the breakdown of acetylcholine, a crucial neurotransmitter involved in memory and attention. Alpha Cognition stated that Zunveyl functions as an allosteric potentiator, enhancing the release of acetylcholine from presynaptic neurons.1 “I am very excited about the approval of Zunveyl, which we believe offers better tolerability for patients with Alzheimer’s disease. We have always believed in ...
- Source: drugdu
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- July 31, 2024
GSK, Flagship Pioneering Commit $150M to Start R&D Pact for Novel Drugs and Vaccines

Respiratory disease and immunology are the initial focus areas of GSK’s new drug discovery partnership with Flagship Pioneering. A similar Flagship alliance with Pfizer recently announced it is pursuing novel obesity treatments. By Frank VinluanGSK already has a strong presence in respiratory disease and immunology, two of its core therapeutic areas. The pharmaceutical giant is now teaming up with Flagship Pioneering in an alliance intended to discover novel medicines to bolster its pipelines in both disease categories. The deal announced Monday calls for the partners to fund up to $150 million up front for an exploration phase intended to identify concepts that can leverage the technologies of Flagship’s portfolio companies. Flagship forms and incubates startups, each one based on a platform technology that focuses on some aspect of biology. The research stemming from these platforms informs the discovery and development of novel medicines. The best known of these “bioplatform” companies ...
- Source: drugdu
- 112
- July 31, 2024
Dexcom shares plunge on lower sales outlook

Dexcom lowered its sales forecast for 2024, surprising Wall Street as it lost market share among durable medical equipment (DME) providers and restructured its salesforce. Shares of the company were down 41% Friday morning. The diabetes device firm now expects 2024 revenue of $4 billion to $4.05 billion, a decrease from its previous forecast of $4.2 billion to $4.35 billion. “We have higher expectations for our business than what we experienced this quarter,” CEO Kevin Sayer told investors on Thursday, adding that he expects “more from myself and more from my team going forward.” Sayer attributed the lower sales outlook to three factors: a salesforce restructuring, lower revenue per customer due to rebates, and a loss of market share in the durable medical equipment channel. Those dynamics put Dexcom’s U.S. revenue about $40 million below the company’s internal estimates, CFO Jereme Sylvain said. The company also had about 70,000 fewer ...
- Source: drugdu
- 79
- July 30, 2024

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