| (Published: Thu, 24 Nov 2022 12:45:31 +0000) |
| Highlights of the Self-Testing Provision for Medical Devices in China |
| With the enactment of NMPAās Regulations on the Supervision and Administration of Medical Devices - Order 739 in 2021, the medical device registration process in China has undergone substantial changes. The NMPA has implemented several process-related changes to streamline and improve the device r |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Nov 2022 12:44:58 +0000) |
| Importance of GPP3 Guidelines |
| The Committee on Publication Ethics (COPE) was established in 1997 to address research and publishing ethics violations. Its goal was to identify workable solutions to the problems and create best practices. It is a non-profit organization that offers a discussion forum and guidance to scientific ed |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Nov 2022 12:44:22 +0000) |
| Steps to Stop Counterfeit Drugs and Enhance Traceability through Web3 and NFTs |
| As the world is moving towards digital transformation, the introduction of various tools is empowering many industries, including Pharmaceuticals and Life Sciences. In fact, the serialization and traceability of items can be improved even further as the world transitions to a digital economy. Curren |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Nov 2022 12:43:49 +0000) |
| ANVISAās Updated Resolution for Brazilian Good Manufacturing Practices |
| This article talks about the ANVISAās updated resolution for granting or renewing the Brazilian Good Manufacturing Practice (BGMP) certification for medical devices. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Nov 2022 12:38:14 +0000) |
| DMA Revises Submission Deadline for Marketing Authorization MA and Clinical Trial Applications |
| This article talks about the DMA's (Danish Medicines Agency) Revised 2022 submission deadline for Marketing Authorization (MA) and clinical trial applications. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Nov 2022 12:37:42 +0000) |
| Differences between FMEA and ISO 14971 Standards for Medical Devices |
| Risk management is a critical activity across all phases of the medical device lifecycle as it directly affects the safety and well-being of patients. Risks are unavoidable; however, they can be curtailed if companies are aware of impending hazards and follow effective risk management procedures |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Nov 2022 12:35:58 +0000) |
| Mexico's COFEPRIS New Requirements for Online Medical Device Submissions |
| This article talks about the Mexico's COFEPRIS announcement on new regulatory requirements for online medical device submissions |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Nov 2022 12:34:46 +0000) |
| eDMS Platform for Successful Regulatory Operations - Freyr rDMS |
| This article talks about the Freyr rDMS, an electronic document management system(eDMS) and its ideal feautures for successful global regulatory operations. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Nov 2022 12:34:03 +0000) |
| Packaging Security for Brand Protection in the Emerging Markets |
| This article talks about the 360 degree packaging security for brand protection in the emerging markets of the pharmaceutical industry to ensure anti-counterfeiting |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 01 Nov 2022 13:26:07 +0000) |
| CGT exclusivity for an Incentivized Pathway to ANDA Submission |
| Competitive generics are known to be a boon as they pave the way to a lucrative market, provided drug manufacturers can decode the challenging and complicated drug development. Although drug development technologies are constantly evolving, we are yet to comprehend the outcomes of Competitive Generi |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 01 Nov 2022 13:25:38 +0000) |
| Adoption of Artificial IntelligenceAI in Medical Writing |
| "The pharmaceutical and Life Sciences sectors have seen a steady increase in the need for Medical Writing. Patents have been expiring, Regulatory standards have changed quickly, and spending on research and development has been rising constantly. Because of this, the necessity to continuously adapt, |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 01 Nov 2022 05:22:26 +0000) |
| Top 10 FAQs about Korean License Holder KLH |
| Top 10 FAQs about Korean License Holder (KLH)
This article talks about the top 10 Frequently Asked Questions (FAQs) about Korean License Holder (KLH) for MFDS device registration.
FAQs, South Korea, Korean License Holder, KLH, Regulatory Affairs, Medical Devices, MFDS, Device registration |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 01 Nov 2022 05:20:54 +0000) |
| Top FAQs about Medical Device Single Audit Program MDSAP |
| Top FAQs about Medical Device Single Audit Program (MDSAP)
This article talks about the top FAQs about Medical Device Single Audit Program (MDSAP) for auditing and monitoring the QMS of medical device manufacturers.
ANVISA, FDA, Medical Devices, Medical Device Single Audit Program, MDSAP, Auditing |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 01 Nov 2022 05:20:19 +0000) |
| Classification of Medical Devices under EU MDR |
| This article talks about the classification of medical devices under EU MDR and EU IVDR. Medical Devices, Competent Authority, EU MDR, EU IVDR, digital health, In Vitro Diagnostic devices, Product Classification
Classification of Medical Devices under EU MDR |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 26 Oct 2022 05:24:51 +0000) |
| Significance of Pharmacogenomic Biomarkers in Biological Drug Labeling as per USFDA |
| This article talks about the USFDA perspective on significance of pharmacogenomic biomarkers in biological drug labeling. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 26 Oct 2022 05:24:21 +0000) |
| NMPA's Regulatory Landscape for Digital Health Technologies in China |
| This article talks about the NMPA released regulatory landscape for digital health technologies in China. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Fri, 21 Oct 2022 14:31:07 +0000) |
| Determination of F-value for child-resistant packaging |
| This article talks about the determination of the F-value to make the child-resistant packaging in Pharmaceuticals for compliant market entry. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Fri, 21 Oct 2022 14:29:49 +0000) |
| Importance of a Technical Writer for Medical Device Manufacturers |
| This article talks about the importance of a technical writer for medical device manufacturers for compliant documentation. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Fri, 21 Oct 2022 14:27:28 +0000) |
| ANVISA Approves Key Drugs and Vaccines to Fight Against Monkeypox |
| This article talks about the ANVISA approved key drugs and vaccines to fight against Monkeypox in Brazil.Monkeypox, Monkeypox virus, Drugs and Vaccines, Tecovirimat, Jynneos Vaccine, Imvanex Vaccine, ANVISA, Prescription Drugs, Regulatory Medical Writing, Infection Control |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 19 Oct 2022 08:49:27 +0000) |
| Transition from eCTD version 3.2.2 to eCTD version 4.0 |
| This article talks about the transition from eCTD version 3.2.2 to eCTD version 4.0 and its benefits for compliant electronic submissions.
eCTD, eCTD tool, Freyr SUBMIT PRO, USFDA, eCTD v4.0, eCTD v3.2.2, electronic submissions |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 19 Oct 2022 08:47:00 +0000) |
| Doās and Donāts of Class I Self-certification under the EU MDR |
| This article talks about the Doās and Donāts of Class I Self-certification under the EU MDR.
self-certification, class I devices, Medical Devices, Regulatory Affairs, EU MDR, digital health, MDD, Device Classification, European Union |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 19 Oct 2022 08:46:01 +0000) |
| Dos and Donāts for CE Certification of Class I Sterile Medical Devices |
| This article talks about the dos and donāts for CE certification of Class I sterile medical devices in the European Union. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Fri, 07 Oct 2022 15:31:41 +0000) |
| An Insightful Webinar on Abbreviated SmPC for New Take on Promotional Materials in the EU |
| This webinar is all about abbreviated SmPC for new take on promotional materials in the EU, join us for the webinar on October 28, 2022. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 29 Sep 2022 13:51:39 +0000) |
| Roadmap to the FDAās Real World DataRWD and Real World EvidenceRWE Submissions |
| During the COVID-19 pandemic, Real-World Data (RWD) and Real-World Evidence (RWE) were essential sources of information for the United States Food and Drug Administration (USFDA) to expedite the approvals of COVID-19 vaccines and therapeutics and to allow other clinical studies to progress under the |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 29 Sep 2022 13:50:56 +0000) |
| FSSAI Amends Food Labelling & Display Regulations |
| The Food Safety and Standards Authority of India (FSSAI) released a Draft Notification on September 14, 2022, amending the Food Safety and Standards (Labeling & Display) Regulations, 2020. These regulations may be called the Food Safety and Standards (Labeling & Display) Amendment Regulations, 2022 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 29 Sep 2022 13:50:08 +0000) |
| Chinaās NMPA Proposed Implementing Regulations for the Drug Administration Law |
| "The National Medical Products Administration (NMPA) of China recently released a comprehensive draft amendment for implementing the China Drug Administration Law (DAL).
The draft amendment introduces significant changes to the Regulatory framework. It encodes the various Regulatory initiatives |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 29 Sep 2022 13:49:31 +0000) |
| CMDh guidance for MAHs on Nitrosamine Impurity Confirmatory Testing |
| "According to the CMDh practical guidance for Marketing Authorization Holders (MAHs) of nationally authorized products, the evaluation of nitrosamine impurity or cross-contamination in a marketed product is a critical criterion. Nitrosamines are proven to be carcinogenic and can affect the overall o |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 20 Sep 2022 15:31:55 +0000) |
| Regulations for Pharmaceutical Advertising in Europe |
| In the European Union (EU), the promotion of medicinal products is governed by advertising laws and regulations. Particularly, the Directive 2001/83/EC of āthe European Parliament and of the Council of 6 November 2001, on the Community code relating to medicinal products for human use,ā establis |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 20 Sep 2022 15:31:02 +0000) |
| Need of Automated Regulatory Intelligence ARI to Life Science industry |
| Regulations stand crucial for any industry that functions in the Life Sciences domain, which is the third most heavily regulated sector after the Aviation & Financial sectors. Non-compliance with regulations comes at a high cost ā the patientsā lives, heavy economic penalties, or loss of reputat |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 20 Sep 2022 15:29:54 +0000) |
| Overview on Global Heavy Metal Limits for Cosmetics |
| Heavy metals are ubiquitously present in the environment surrounding us. Heavy metals containing ingredients such as thimerosal (mercury) and lead acetate were used as cosmetic ingredients in the past. They were also used as reaction catalysts during chemical synthesis and for manufacturing industri |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 20 Sep 2022 15:29:21 +0000) |
| Green Cosmetics for Sustainable Beauty |
| As public awareness of environmental issues is increasing rapidly, many cosmetic companies are engaging their focus on natural and environment-friendly emulsifiers and chemicals to be used in their products. The advantages of āgreenā beauty products go beyond fashion. Newer research approaches h |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 08 Sep 2022 09:43:38 +0000) |
| An Exclusive Webinar on Foundation Masterclass - 510k Clearance Pathway |
| This webinar is all about understanding the US FDAās 510(k) Clearance Pathway for Medical device compliance, join us for the webinar on September 07, 2022. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 08 Sep 2022 09:43:07 +0000) |
| Role of a Scientific Writer in Social Media |
| This article talks about the role of a scientific writer for social media engagement in life science marketing |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Fri, 12 Aug 2022 07:02:07 +0000) |
| Guidance on Procedural Aspect for the consultation of Companion Diagnostics CDx |
| Companion Diagnostics (CDx) are In Vitro Diagnostic devices used in conjunction with therapeutic drugs to determine their suitability for the patients. To place the CDx in the European Union, the manufacturer is required to submit technical and other relevant documents to the Notified Body (NB) for |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 11 Aug 2022 12:20:14 +0000) |
| Regulations of Software as Medical Device SaMD in India |
| The emergence of digital health technologies has fast-tracked the evolution of the healthcare sector. New-age healthcare products like wearables, telemedicine, and clinical decision-making tools use Artificial Intelligence (AI) and Machine Learning (ML) algorithms. Global Health Agencies, including |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 11 Aug 2022 12:19:39 +0000) |
| Significance of ICSRs in Pharmacovigilance: The EU Perspective |
| "Developing novel and essential medicinal products has significantly increased the burden of monitoring and tracking the Adverse Drug Reactions (ADRs) and Adverse Events (AEs) of drug products. An Individual Case Study Report (ICSR) is collected at an individual level, which leads to causality asses |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 11 Aug 2022 12:18:41 +0000) |
| Strategies to Prevent Regulatory eCTD Submission Mishaps |
| "Over the years, procedures for assembling and filing eCTD submissions have evolved tremendously. Non-adherence to the submission requirements may occur when documents are not relevant to fit seamlessly into the given eCTD format. In such scenarios, applicants are burdened with making last-minute am |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 08 Aug 2022 15:29:47 +0000) |
| Labeling Requirements for California's Cleaning Products |
| Cleaning product labels are no different than labels for other consumer goods when disclosure of ingredients comes into play. Organizations should exercise safety practices that will protect the consumers and workers during consumption. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 08 Aug 2022 15:26:52 +0000) |
| Overview on Electronic Product Information ePI Labeling |
| In 1999, the European Medicines Assessment Agency (EMEA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) set out to design a new system to share product information electronically to support the submission of new products or variations post-approval. This was called |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 08 Aug 2022 15:26:10 +0000) |
| An Overview on Quality Review of Document QRD |
| This article talks about the overview on Quality Review of Document (QRD) of medicines in Europe
To market medicinal products in the European Union (EU) countries, pharmaceutical companies must prepare and translate documents like the Summary of Product Characteristics (SmPCs), Patient Information |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 04 Aug 2022 14:06:58 +0000) |
| South Koreaās MFDS regulations on AI-based Medical Devices |
| The technological advancement is now an integral part of healthcare and Artificial Intelligence (AI) algorithms, along with other AI-powered applications supporting medical professionals in clinical settings. AI and Machine Learning (ML)-based Software as a Medical Device (SaMD) aid medical practiti |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 04 Aug 2022 14:06:05 +0000) |
| Role of Marketing Authorization Holder MAH for medical device registration in Japan |
| Globally, the Health Agencies require foreign medical devices and IVD manufacturers to appoint a local representative. In Japan, under the revised Pharmaceuticals and Medical Device (PMD) Act, the In-Country Caretaker (ICC) system was replaced with Marketing Authorization Holder (MAH) system. Under |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 25 Jul 2022 15:28:59 +0000) |
| Key requirements for Pharmaceutical Serialization |
| With serialization legislation introduced in two (02) major drug markets, namely, the USA and the EU, the pharma industry is being forced to take action on a large scale. On the other side, people are slowly realizing the benefits that serialization could bring in terms of patient safety and supply |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 25 Jul 2022 15:28:18 +0000) |
| Evolving with Pharmaceutical Serialisation, Tracking and Tracing |
| "In-depth analyses will highlight how pharmaceutical packaging, labeling, serialization, tracking, and traceability enhance consumer safety and transparency in the supply chain, as well as benefit pharmaceutical packaging that go beyond compliance with laws.
As the pharmaceutical industry continu |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 30 Jun 2022 07:15:08 +0000) |
| Regulatory Intelligence RI: The Focal Point of Your Business |
| This article talks about the importance of integrating Regulatory Intelligence (RI) Solutions with your Business to overcome the current challenges in the industry. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 30 Jun 2022 07:14:09 +0000) |
| EMAās Perspective on the Future of Medicines Regulations |
| This article talks about the EMAās perspective on the future of medicines regulations. The prime goal of a Health Authority (HA) is to promote and protect the interests of those it serves by amending and introducing new regulations. The European Medicines Regulatory Network (EMRN) is a network of |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 30 Jun 2022 07:13:15 +0000) |
| Steps for the pharmaceutical organizations for successful regulatory submissions |
| This article talks about the measures that pharmaceutical organizations must take for successful regulatory submissions. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 30 Jun 2022 07:12:43 +0000) |
| EMA's Pharmacovigilance Activities to identify an alert signal |
| This article talks about the trigger for EMA's Pharmacovigilance Activities to identify an alert signal. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 30 Jun 2022 07:12:03 +0000) |
| South Koreaās UDI Compliance Requirements for Medical Device Registrations |
| This article talks about the South Koreaās UDI compliance requirements for Medical Device registrations. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 20 Jun 2022 05:25:34 +0000) |
| Quality by Design QbD- An Enhanced Route for Drug Development |
| Over the decades, advancements in treatment procedures have brought about necessary amendments to the Regulatory framework. From Active Pharmaceutical Ingredient (API) identification to its placement on the patientās side table, the core of innovating novel treatment protocols revolves around thre |
| Author: Freyr Solutions Inc |
| Directory: Health |
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