Title: Épidémie d’Ébola de 2014 en Afrique occidentale

URL: http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/ucm411646.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 French. 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: 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: 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: Vaccine Adverse Event Reporting System (VAERS)

URL: https://vaers.hhs.gov/

Collection: Global Health Events web archive

Description: Website for Vaccine Adverse Event Reporting System regarding reactions to the vaccine, links to resources, ways to reports, submitting follow-up information, helpful links, learning tools and vaccine safety information

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Title: U.S. FDA (@US_FDA) | Twitter

URL: https://twitter.com/US_FDA/

Collection: Global Health Events web archive

Description: Twitter account page for the Food and Drug Administration (FDA).

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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: 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: Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions | FDA

URL: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/pfizer-biontech-covid-19-vaccine-frequently-asked-questions

Collection: Global Health Events web archive

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Title: Novel coronavirus (2019-nCoV) | FDA

URL: https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/novel-coronavirus-2019-ncov/

Collection: Global Health Events web archive

Description: Page on the US Food and Drug Administration (USDA) website featuring the most recent information and updates on the Novel coronavirus (COVID-19).

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Title: NIOSH-Approved Disposable Filtering Facepiece Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency EUA (Emergency Use Authorization)

URL: https://www.fda.gov/media/135763/download

Collection: Global Health Events web archive

Description: This nine-page letter, reissued multiple times, authorizes certain National Institute for Occupational Safety and Health (NIOSH)-approved respirators not currently regulated by the Food and Drug Administration (FDA) to be used in a health care setting by health care personnel during the coronavirus (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system. When properly fitted, respirators, such as N95s, can filter more airborne particles than face masks, which is important during an outbreak of a respiratory disease like COVID-19.

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Title: Multilingual COVID-19 Resources | FDA

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

Collection: Global Health Events web archive

Description: Website from U.S. Food and Drug Administration regarding multilingual COVID-19 Resources and COVID-19 Vaccine myths with links for simplified Chinese, Korean, Tagalog, Vietnamese, Portuguese, Hmong, and Somali

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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: 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: Fact Sheet for Healthcare Providers: TaqPath COVID-19 Combo Kit

URL: https://www.fda.gov/media/136111/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: NeuMoDx SARS-CoV-2 Assay - NeuMoDx Molecular, Inc.

URL: https://www.fda.gov/media/136564/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 NeuMoDx SARS-CoV-2 Assay, which received an Emergency Use Authorization from the Food and Drug Administration on March 30, 2020. The NeuMoDx SARS-CoV-2 Assay is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: Emergency Use of the B. Braun Space and Outlook Pumps During the COVID-19 Pandemic

URL: https://www.fda.gov/media/136895/download

Collection: Global Health Events web archive

Description: The Food and Drug Administration issued an Emergency Use Authorization (EUA) for the emergency use of the Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, and Outlook ES (Braun Space and Outlook Pumps) for use in the tracheal delivery of continuous nebulized medications into a nebulizer to treat patients of all ages with or suspected of having COVID-19 and decrease the exposure of healthcare providers to such patients during the COVID-19 pandemic. The EUA was also issued for ground medical transport use of the Infusomat Space Volumetric Infusion Pump System.

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Title: Fact Sheet for Healthcare Providers: Emergency Use of Seraph 100 Microbind Affinity Blood Filter for COVID-19

URL: https://www.fda.gov/media/137102/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 Seraph 100 Microbind Affinity Blood Filter device for the reduction of pathogens and inflammatory mediators. The Seraph 100 Microbind Affinity Blood Filter device was authorized for emergency use by the Food and Drug Administration on April 17, 2020, to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

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

URL: https://www.fda.gov/media/137170/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. These compatible N95 respirators have been decontaminated using the Sterilucent HC 80TT Vaporized Hydrogen Peroxide (VHP) Sterilizer. Decontaminated N95 respirators that have been decontaminated using the Sterilucent Sterilization System are authorized for single-user reuse by healthcare personnel in a healthcare setting during the COVID-19 pandemic.

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Title: Fact Sheet for Healthcare Personnel: STERIS Sterilization Systems for Decontaminating Compatible N95 Respirators

URL: https://www.fda.gov/media/136846/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 the STERIS N95 Respirator Decontamination Cycle (Non-Lumen Cycle) in STERIS V-PRO 1 Plus, V-PRO maX, and V-PRO maX2 Sterilizers.

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Title: Fact Sheet for Healthcare Personnel: Battelle Decontamination System for Decontaminating Compatible N95 Respirators

URL: https://www.fda.gov/media/136530/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 N95 or N95-equivalent respirators. These compatible N95 or N95-equivalent respirators have been decontaminated using the Battelle CCDS Critical Care Decontamination Systemâ„¢. The document is for healthcare personnel who have been given a decontaminated N95 or N95- equivalent respirator that has been decontaminated using a decontamination system for reuse by healthcare personnel in a healthcare setting to help prevent healthcare personnel exposure to pathogenic biologic airborne particulates during the COVID-19 pandemic.

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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 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 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 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: 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: 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: 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 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 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 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 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: 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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