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National Library of Medicine

Archive-It Partner Since: Mar, 2009

Organization Type: National Institutions

Organization URL: http://www.nlm.nih.gov/   

Description:

The National Library of Medicine (NLM), the world's largest medical library and a component of the National Institutes of Health, collects, preserves, and makes available to the public information about health, medicine, and the biomedical sciences. To continue fulfilling this mission, NLM is collecting and archiving related Web content, which also serves to document the histories of health and medicine. For questions about our web archiving program contact us at nlmwebcollecting@nlm.nih.gov.

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Title: Fact Sheet for Healthcare Personnel: ASP STERRAD Sterilization System for Decontaminating Compatible N95 Respirators

URL: https://www.fda.gov/media/136881/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare personnel of the significant known and potential risks and benefits of the emergency use of decontaminated, compatible N95 respirators during the COVID-19 pandemic. These compatible N95 respirators have been decontaminated using one of three Advanced Sterilization Products STERRAD Sterilization Systems, using the STERRAD Sterilization Cycles for N95 respirator decontamination: STERRAD 100S Cycle, STERRADNX Standard Cycle, or STERRAD100NX Express Cycle.

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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: FDA warns consumers about fraudulent Ebola treatment products

URL: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm410086.htm

Collection: Global Health Events web archive

Description: Press release titled, "FDA warns consumers about fraudulent Ebola treatment protocols," published on the Food and Drug Administration (FDA) website on August 14, 2014. The statement provides factual information regarding Ebola treatments.

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Title: FDA approves first buprenorphine implant for treatment of opioid dependence | FDA

URL: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm503719.htm

Collection: Opioid Epidemic web archive

Description: Press release published on the U.S. Food and Drug Administration (FDA) Website on May 26, 2016. The Press release discusses the FDA approval of the first buprenorphine implant (Probuphine) for treatment of opioid dependence.

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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: 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: 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: 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: FDA Medical Countermeasures Initiative (@FDA_MCMi) | Twitter

URL: https://twitter.com/FDA_MCMi/

Collection: Global Health Events web archive

Description: Twitter account page for the Food and Drug Administration (FDA) Medical Countermeasures Initiative (MCMi).

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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 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 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: 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: 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: 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: 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: Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

URL: https://www.fda.gov/media/137079/download

Collection: Global Health Events web archive

Description: This 10-page guidance has been issued to provide a policy to help expand the availability of telethermographic systems used for body temperature measurements for triage use for the duration of the COVID-19 public health emergency.

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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 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 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 Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency

URL: https://www.fda.gov/media/136540/download

Collection: Global Health Events web archive

Description: The Food and Drug Administration (FDA) has issued an immediately-in-effect guidance to help expand the availability of surgical apparel for healthcare professionals, including gowns (togas), hoods, and surgeon's and patient examination gloves during this COVID-19 public health emergency. FDA believes the policy set forth in this 15-page guidance may help address the urgent public health concerns caused by shortages of such products by taking a risk-based approach and clarifying the policies that FDA intends to apply to gowns and other apparel, including these products' associated indications and claims.

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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: 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: Donate COVID-19 Plasma | FDA

URL: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/donate-covid-19-plasma

Collection: Global Health Events web archive

Description: Website from the Food and Drug Administration on donating COVID-19 plasma. Includes a video with information on donation, frequently asked questions, and other resources.

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Title: Coronavirus Testing Basics | FDA

URL: https://www.fda.gov/consumers/consumer-updates/coronavirus-testing-basics/

Collection: Global Health Events web archive

Description: Website from the US Food and Drug Administration, "Coronavirus Disease 2019 Testing Basics", with information on COVID-19 testing and other resources.

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

URL: https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19/

Collection: Global Health Events web archive

Description: Website for COVID-19 related resources produced and curated by the U.S. Food & Drug Administration (FDA).

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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: 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: 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: 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: 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: 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 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 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 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 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 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 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 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 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: COVID-19 Emergency Use Authorization: Manufacturers of Face Shields; Health Care Personnel; Hospital Purchasing Departments and Distributors; and Any Other Stakeholders

URL: https://www.fda.gov/media/136842/download

Collection: Global Health Events web archive

Description: The U.S. Food and Drug Administration (FDA) has issued this six-page Emergency Use Authorization (EUA) in response to concerns relating to insufficient supply and availability of face shields for use by healthcare personnel as personal protective equipment (PPE) in healthcare settings in accordance with Centers for Disease Control and Prevention recommendations to cover the front and sides of the face and provide barrier protection during the coronavirus disease 2019 (COVID-19) pandemic.

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Title: Brote de la enfermedad del Ébola en África Occidental de 2014

URL: http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/ucm411643.htm

Collection: Global Health Events web archive

Description: Page on the US Food and Drug Administration (USDA) website featuring the most recent updates on the Ebola response at the Food and Drug Administration (FDA) in Spanish. The FDA is working to expedite the development and availability of medical products, including treatments, vaccines, diagnostic tests, and personal protective equipment, that may help to end the Ebola epidemic in West Africa.

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Title: Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments | FDA

URL: https://www.fda.gov/consumers/consumer-updates/beware-fraudulent-coronavirus-tests-vaccines-and-treatments/

Collection: Global Health Events web archive

Description: Website from U.S. Food and Drug Administration regarding fraudulent COVID-19 tests, vaccines and treatments

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Title: Announcing the Winner of the 2016 FDA Naloxone App Competition

URL: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm533711.htm

Collection: Opioid Epidemic web archive

Description: Press release published on the U.S. Food and Drug Administration (FDA) Website announcing the winner of the 2016 FDA Naloxone app competition. The winning app, OD Help, was developed as a simple, easy-to-use mobile app that connects potential opioid overdose victims with a crowd-sourced network of naloxone carriers.

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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: 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: 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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URL: https://www.fda.gov/media/136471/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 Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV, which received an Emergency Use Authorization from the Food and Drug Administration on March 26, 2020. The Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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

Collection: Global Health Events web archive

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