Title: Fact Sheet for Healthcare Providers: STANDARD M nCoV Real-Time Detection kit - SD BIOSENSOR, Inc.

URL: https://www.fda.gov/media/137301/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the STANDARD M nCoV Real-Time Detection kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 23, 2020. The STANDARD M nCoV Real-Time Detection kit is authorized for use on respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.

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Title: Frequently Asked Questions on the Revocation of the Emergency Use Authorization for Hydroxychloroquine Sulfate and Chloroquine Phosphate

URL: https://www.fda.gov/media/138946/download

Collection: Global Health Events web archive

Description: This three-page fact provides answers to frequently asked questions about the revocation of the Emergency Use Authorization for hydroxychloroquine sulfate and chloroquine phosphate to treat COVID-19. The Food and Drug Administration has determined that these drugs are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA.

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Title: Letter to Eli Lilly & Company from the US Food & Drug Administration Re: Emergency Use Authorization 090

URL: https://www.fda.gov/media/143602/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Recipients and Caregivers: EUA of the Pfizer-Biontech COVID-19 Vaccine to Prevent COVID-19 in Individuals 16 Years of Age and Older

URL: https://www.fda.gov/media/144414/download

Collection: Global Health Events web archive

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Title: Regeneron Letter of Authorization, February 25, 2021

URL: https://www.fda.gov/media/145610/download

Collection: Global Health Events web archive

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Title: Vaccines and Related Biological Products Advisory Committee Meeting February 26, 2021

URL: https://www.fda.gov/media/146217/download

Collection: Global Health Events web archive

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Title: Vaccines and Related Biological Products Advisory Committee Meeting

URL: https://www.fda.gov/media/146269/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers)

URL: https://www.fda.gov/media/146304/download

Collection: Global Health Events web archive

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URL: https://www.fda.gov/media/157720/download

Collection: Global Health Events web archive

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Title: FDA Briefing Document - Vaccines and Related Biological Products Advisory Committee Meeting

URL: https://www.fda.gov/media/159452/download

Collection: Global Health Events web archive

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Title: 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic | FDA

URL: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/3d-printing-medical-devices-accessories-components-and-parts-during-covid-19-pandemic

Collection: Global Health Events web archive

Description: This web page provides answers to frequently asked questions for entities who use 3D printing of devices, accessories, components, and/or parts during the COVID-19 emergency. The Food and Drug Administration recognizes that the public may seek to use 3D printing to assist in meeting demand for certain products during the COVID-19 pandemic.

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Title: Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents | FDA

URL: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/adverse-event-reporting-medical-devices-under-emergency-use-authorization-eua-or-discussed-covid-19

Collection: Global Health Events web archive

Description: This web page answers questions about adverse event reporting for medical devices distributed under Emergency Use Authorizations (EUAs) or that are the subject of COVID-19-related guidance documents, and points out a number of adverse event reporting-related resources.

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Title: FAQs on Testing for SARS-CoV-2 | FDA

URL: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2

Collection: Global Health Events web archive

Description: This web page, updated regularly, provides answers to frequently asked questions relating to the development and performance of tests for SARS-CoV-2.

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Title: Hospital Beds, Stretchers, and Mattresses During the COVID-19 Pandemic | FDA

URL: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/hospital-beds-stretchers-and-mattresses-during-covid-19-pandemic

Collection: Global Health Events web archive

Description: This web page is intended to address questions related to the design, evaluation, labeling, and marketing of hospital beds, stretchers, and mattresses during the COVID-19 public health emergency.

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Title: Medical Device Shortages During the COVID-19 Public Health Emergency | FDA

URL: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-device-shortages-during-covid-19-public-health-emergency

Collection: Global Health Events web archive

Description: Website from the U.S. Food and Drug Administration regarding medical devise shortages during COVID-19 public health emergency.

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Title: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests | FDA

URL: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests

Collection: Global Health Events web archive

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Title: FAQs on Emergency Use Authorizations (EUAs) for Medical Devices Related to COVID-19 | FDA

URL: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/faqs-emergency-use-authorizations-euas-medical-devices-related-covid-19

Collection: Global Health Events web archive

Description: This web page provides answers to frequently asked questions about Emergency Use Authorizations (EUAs) and medical devices during the COVID-19 pandemic.

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Title: Coronavirus (COVID-19) and Medical Devices | FDA

URL: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/coronavirus-covid-19-and-medical-devices

Collection: Global Health Events web archive

Description: Website from the U.S. Food and Drug Administration regarding COVID-19 and medical devices, includes information about in vitro diagnostic tests, masks and respirators, PPE, ventilators, and other medical devices.

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Title: Emergency Use Authorizations | FDA

URL: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations/

Collection: Global Health Events web archive

Description: Page on the US Food and Drug Administration (USDA) website featuring Emergency Use Authorizations (EUA) for the Coronavirus Disease 2019 (COVID-19), Zika Virus, 2014 Ebola Virus outbreak, and other global pandemics.

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Title: Fact Sheet for Health Care Professionals: Interpreting CDC Novel Coronavirus 2012 Real-time RT-PCR Assay Test Results | FDA

URL: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/fact-sheet-health-care-professionals-interpreting-cdc-novel-coronavirus-2012-real-time-rt-pcr-assay

Collection: Global Health Events web archive

Description: This resource provides information about the Food and Drug Administration (FDA)'s issuance of an Emergency Use Authorization (EUA) for the Centers for Disease Control and Prevention (CDC) Novel Coronavirus 2012 Real-time RT-PCR Assay to test for the presumptive presence of Middle East respiratory syndrome coronavirus (MERS-CoV) in the following clinical specimens: upper respiratory specimens, such as nasopharyngeal swabs and oropharyngeal swabs; lower respiratory specimens, such as bronchoalveolar lavage, bronchial wash, tracheal aspirate, and sputum; serum; and stool.

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Title: Webinar - Enforcement Policy for Personal Protective Equipment (PPE) During COVID-19: Immediately in Effect Guidance - 04/06/2020 - 04/06/2020 | FDA

URL: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-enforcement-policy-personal-protective-equipment-ppe-during-covid-19-immediately-effect

Collection: Global Health Events web archive

Description: This one-hour webinar was held for device manufacturers and industry to discuss and answer questions on the recently issued, immediately in effect guidances on enforcement policy for personal protective equipment (PPE) during COVID-19. The two guidances discussed were Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised); and Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency.

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Title: Addressing New Variants: A Federal Perspective On The Covid-19 Response - 01/11/2022 | FDA

URL: https://www.fda.gov/news-events/congressional-testimony/addressing-new-variants-federal-perspective-covid-19-response-01112022

Collection: Global Health Events web archive

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Title: Press Announcements | FDA

URL: https://www.fda.gov/news-events/fda-newsroom/press-announcements/

Collection: Global Health Events web archive

Description: Website from U.S. Food and Drug Administration, up to date press announcements

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Title: FDA Protects Patients and Consumers from Fraud During COVID-19 | FDA

URL: https://www.fda.gov/news-events/fda-voices/fda-protects-patients-and-consumers-fraud-during-covid-19/

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dose-certain-immunocompromised

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0/

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19 | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibody-treatment-covid-19/

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expands-eligibility-pfizer-biontech-covid-19-vaccine-booster-dose

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-policies-guide-medical-product-developers-addressing-virus/

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-certain-monoclonal-antibodies-treat-covid-19-due-omicron

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-janssen-covid-19-vaccine-certain-individuals

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-updated-guidance-address-urgent-need-blood-during-pandemic

Collection: Global Health Events web archive

Description: This web page provides guidance for immediate implementation to address the urgent and immediate need for blood and blood components during the COVID-19 pandemic. The FDA has concluded that current policies regarding certain donor eligibility criteria can be modified without compromising the safety of the blood supply.

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Title: Coronavirus (COVID-19) Update: FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-updated-guidance-address-urgent-need-blood-during-pandemic/

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab/

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19 | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-federal-judge-enters-temporary-injunction-against-genesis-ii-church

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: October 26, 2021 | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-october-26-2021

Collection: Global Health Events web archive

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Title: FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations | FDA

URL: https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations

Collection: Global Health Events web archive

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Title: FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff | FDA

URL: https://www.fda.gov/news-events/press-announcements/fda-issues-alert-regarding-sars-cov-2-viral-mutation-health-care-providers-and-clinical-laboratory

Collection: Global Health Events web archive

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Title: FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines | FDA

URL: https://www.fda.gov/news-events/press-announcements/fda-statement-following-authorized-dosing-schedules-covid-19-vaccines

Collection: Global Health Events web archive

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Title: Coronavirus Disease 2019 (COVID-19) Resources for Patients | FDA

URL: https://www.fda.gov/patients/coronavirus-disease-2019-covid-19-resources-patients/

Collection: Global Health Events web archive

Description: US Food and Drug Administration web page of coronavirus resources for patients. Includes information on hand sanitizers, testing and treatment options, donating blood and plasma, fake products, medical product shortages, clinical trials, food safety, and the expanded access program.

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Title: Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency | FDA

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-clinical-electronic-thermometers-during-coronavirus-disease-2019-covid-19-public

Collection: Global Health Events web archive

Description: This eight-page guidance provides a policy to help expand the availability of clinical electronic thermometers to address the COVID-19 public health emergency. These devices include both contact and non-contact clinical electronic thermometers.

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Title: Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency | FDA

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-infusion-pumps-and-accessories-during-coronavirus-disease-2019-covid-19-public

Collection: Global Health Events web archive

Description: This 16-page guidance provides a policy to help expand the availability and remote capabilities of infusion pumps and their accessories for health care professionals during the COVID-19 pandemic. These products are used to treat patients who require continuous infusion therapy during the COVID-19 public health emergency.

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Title: Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency | FDA

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-remote-ophthalmic-assessment-and-monitoring-devices-during-coronavirus-disease

Collection: Global Health Events web archive

Description: This 11-page guidance provides a policy to help expand the capability of remote ophthalmic assessment and monitoring devices to facilitate patient care while reducing patient and healthcare provider contact and exposure to COVID-19 during the COVID-19 pandemic.

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Title: Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency | FDA

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-sterilizers-disinfectant-devices-and-air-purifiers-during-coronavirus-disease

Collection: Global Health Events web archive

Description: The Food and Drug Administration (FDA) has issued this immediately-in-effect 14-page guidance that outlines an enforcement policy to help expand the availability and capability of sterilizers, disinfectant devices, and air purifiers. The devices include those intended to make devices sterile, kill pathogens or other microorganisms, and kill pathogens or microorganisms in the air. This policy reflects FDA's commitment to ease burdens on healthcare providers and facilities as they face COVID-19.

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Title: Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency | FDA

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-ventilators-and-accessories-and-other-respiratory-devices-during-coronavirus

Collection: Global Health Events web archive

Description: The Food and Drug Administration has issued this 14-page guidance to provide a policy to help expand the availability of ventilators, as well as other respiratory devices and their accessories, during the COVID-19 pandemic. It lists the devices and accessories that the guidance applies to.

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Title: FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency | FDA

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic/

Collection: Global Health Events web archive

Description: FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency", dated March 2020

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Title: FDA Research, Policy, and Workshops on Women in Clinical Trials | FDA

URL: https://www.fda.gov/science-research/womens-health-research/fda-research-policy-and-workshops-women-clinical-trials/

Collection: Women's Health web archive

Description: Website from U.S. Food and Drug Administration regarding FDA research, policy, and workshops on Women in Clinical Trials.

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Title: Regulations, Guidance, and Reports related to Women’s Health | FDA

URL: https://www.fda.gov/science-research/womens-health-research/regulations-guidance-and-reports-related-womens-health/

Collection: Women's Health web archive

Description: Website from U.S. Food and Drug Administration regarding regulations, guidance, and reports related to Women's Health.

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Title: FDA and CDC Virtual Press Conference: Johnson & Johnson COVID-19 Vaccine - 4/23/2021 - YouTube

URL: https://www.youtube.com/watch?v=Nf_OuB1rBi0

Collection: Global Health Events web archive

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Title: Virtual Press Conference: Updated COVID-19 Vaccine Boosters – 8/31/2022 - YouTube

URL: https://www.youtube.com/watch?v=QNFES1RLf1M

Collection: Global Health Events web archive

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Title: Joint Media Call: FDA & CDC to Discuss Janssen COVID-19 Vaccine - 4/13/2021 - YouTube

URL: https://www.youtube.com/watch?v=_ELXnGYgsJY

Collection: Global Health Events web archive

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