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La FDA aprueba el primer antiviral de ingestión oral para el tratamiento del COVID-19 en adultos
… -primer-antiviral-de-ingestion-oral-para-el-tratamiento-del-covid-19-en-adultos … Englsh Hoy, la Administración de Alimentos y … para administrarse por vía oral) para el tratamiento del COVID-19 de leve a moderado en adultos con alto riesgo de …
FDA and OSHA Team Up to Publish Checklist to Assist Food Industry During COVID-19
… and-osha-team-publish-checklist-assist-food-industry-during-covid-19 … Constituent Update August 19, 2020 As part of our … it operates to ensure supply-chain continuity during the COVID-19 public health emergency. Not only are these …
Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines
… es-action-help-facilitate-timely-development-safe-effective-covid … Español Today, the U.S. Food and Drug Administration … development of safe and effective vaccines to prevent COVID-19 by providing guidance with recommendations for those …
In Vitro Diagnostics EUAs - IVDs for Management of COVID-19 Patients
… s-medical-devices/in-vitro-diagnostics-euas-ivds-management-covid-19-patients … March 24, 2023 - The FDA has finalized two … Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for …
Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines
… vid-19-update-fda-takes-additional-actions-use-booster-dose-covid-19-vaccines … Español Today, the U.S. Food and Drug … took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency is …
SD BIOSENSOR, Issues Notification of Voluntary Recall of ‘STANDARD Q COVID-19 Ag Home Test’
… d-biosensor-issues-notification-voluntary-recall-standard-q-covid-19-ag-home-test … January 31, 2022. SD Biosensor, Inc., a … company, is voluntarily recalling its STANDARD Q COVID-19 Ag Home Test in the United States, due to confirmed …
FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines
… cements/fda-statement-following-authorized-dosing-schedules-covid-19-vaccines … Español Two different mRNA vaccines have now … shown remarkable effectiveness of about 95% in preventing COVID-19 disease in adults. As the first round of vaccine …
Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers
… irus-covid-19-and-medical-devices/antibody-serology-testing-covid-19-information-patients-and-consumers … Español Antibodies … or after vaccination. SARS-CoV-2 is the virus that causes COVID-19. SARS-CoV-2 antibody tests detect antibodies to the …
COVID-19 Real World Data (RWD) Data Elements Harmonization Project
… /drugs/coronavirus-covid-19-drugs/covid-19-real-world-data-rwd-data-elements-harmonization-project … Introduction This project aims to harmonize a list of COVID-19 data elements with several Common Data Models (CDMs) and …
COVID-19 Related Test Data and Reporting: FAQs on Testing for SARS-CoV-2
… ical-devices/coronavirus-covid-19-and-medical-devices/covid-19-related-test-data-and-reporting-faqs-testing-sars-cov-2 … … provides answers to frequently asked questions related to COVID-19 related test data and reporting. Questions and answers …
Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2023
… /vaccines-blood-biologics/updated-covid-19-vaccines-use-united-states-beginning-fall-2023 … FDA's … make recommendations for SARS-CoV-2 strain(s) for updated COVID-19 vaccines for use in the United States beginning in …
Windsor Mill Man Pleads Guilty to Federal Charge for Fraud Scheme Purporting to Sell COVID-19 Vaccines
… n-pleads-guilty-federal-charge-fraud-scheme-purporting-sell-covid-19-vaccines … Department of Justice U.S. Attorney’s Office … the Website of a Biotech Company That Has an Authorized COVID-19 Vaccine to Perpetrate the Scheme Baltimore, Maryland …
Recombinant Protein-Based COVID-19 Vaccines Workshop - 04/27/2023
… eetings-conferences-and-workshops/recombinant-protein-based-covid-19-vaccines-workshop-04272023 … The recording of the Recombinant Protein-Based COVID-19 Vaccines Workshop is available until Thursday, June …
Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - 04/18/2023
… l-devices/medical-devices-news-and-events/webinar-guidances-covid-19-transition-plans-medical-devices-04182023 … Summary … the two final guidances on the Coronavirus Disease 2019 (COVID-19) transition plans for medical devices. During this …
FDA Insight: Vaccines for COVID-19, Part 1
… /news-events/fda-insight/fda-insight-vaccines-covid-19-part-1 … Listen (MP3, 11MB) In Part 1 of FDA Insight’s … Evaluation and Research, to discuss the basics of COVID-19 vaccine development. FDA Insight: Episode 5 – …
Purveyor of Fake COVID-19 Vaccines Sentenced
… nt-and-criminal-investigations/press-releases/purveyor-fake-covid-19-vaccines-sentenced … Department of Justice U.S. Attorney’s … early as March 2, 2020, Stine claimed to have developed a COVID-19 vaccine that he offered to inject in customers for …
Coronavirus (COVID-19) Update: FDA Continues to Combat Fraudulent COVID-19 Medical Products
… coronavirus-covid-19-update-fda-continues-combat-fraudulent-covid-19-medical-products … Español Today, the U.S. Food and Drug … advantage of widespread fear among consumers during the COVID-19 pandemic. In response to scammers on the internet …
COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
… ical-devices/coronavirus-covid-19-and-medical-devices/covid-19-tests-granted-traditional-marketing-authorization-fda … The FDA has been working with COVID-19 test developers seeking to pursue marketing authorization …
Pruebas de COVID-19 de venta libre para diagnóstico en casa falsificadas
… devices/coronavirus-covid-19-and-medical-devices/pruebas-de-covid-19-de-venta-libre-para-diagnostico-en-casa-falsificadas … … o utilizando en los Estados Unidos pruebas de COVID-19 de venta libre para diagnóstico en casa …
FDA Takes Steps to Increase Availability of COVID-19 Vaccine
… s/press-announcements/fda-takes-steps-increase-availability-covid-19-vaccine … Español Following careful review and … needed supply of the Janssen (Johnson & Johnson) COVID-19 Vaccine to be made available. The agency is …
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
… availability of a final guidance for industry entitled “COVID-19: Developing Drugs and Biological Products for Treatment … and biological products for the treatment or prevention of COVID-19. This guidance describes FDA’s current …
Pruebas de diagnóstico de COVID-19 realizadas en casa: Preguntas frecuentes
… irus-covid-19-and-medical-devices/pruebas-de-diagnostico-de-covid-19-realizadas-en-casa-preguntas-frecuentes … English 12 de … de salud pública (PHE, por sus siglas en inglés) de COVID-19 declarada bajo la sección 319 de la Ley del Servicio …
Development and Licensure of Vaccines to Prevent COVID-19
… idance-documents/development-and-licensure-vaccines-prevent-covid-19 … Vaccines … FDA is issuing this guidance to assist … vaccines for the prevention of Coronavirus Disease 2019 (COVID-19) which is caused by severe acute respiratory …
A Closer Look at COVID-19 Diagnostic Testing
… /health-professionals/closer-look-covid-19-diagnostic-testing … The FDA has worked around the clock … diagnostic tests, to fight the coronavirus disease 2019 (COVID-19) pandemic. A patient and consumer overview 1 of …
Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits
… 9-update-fda-alerts-consumers-about-unauthorized-fraudulent-covid-19-test-kits … Español The U.S. Food and Drug Administration … any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part …