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Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine
… s-announcements/joint-cdc-and-fda-statement-johnson-johnson-covid-19-vaccine … Español As of April 12, more than 6.8 million … now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal …
La FDA autoriza vacuna contra el COVID-19 de Pfizer-BioNTech para uso de emergencia en niños de 5 a 11 años de edad
… /press-announcements/la-fda-autoriza-vacuna-contra-el-covid-19-de-pfizer-biontech-para-uso-de-emergencia-en-ninos-de-5-11 … autorizó el uso de emergencia de la vacuna contra el COVID-19 de Pfizer-BioNTech para la prevención del COVID-19 para …
Using real-world evidence to advance COVID-19 medical countermeasures
… se/mcm-regulatory-science/using-real-world-evidence-advance-covid-19-medical-countermeasures … Background | Project description … Project dates: September 2021 - September 2023 Background COVID-19 has created an unprecedented challenge to public …
Actualización sobre el COVID-19: El USDA y la FDA enfatizan que la información epidemiológica y científica actual indica que no hay transmisión del COVID-19 a través de los alimentos o de los envases de los alimentos
… año de que el brote de la enfermedad por coronavirus 2019 (COVID-19) fuera declarado una emergencia de salud mundial, el … agudo severo 2 (SARS-CoV-2), el virus causante del COVID-19. Nuestra confianza en la seguridad del suministro de …
FDA Insight: Vaccines for COVID-19, Part 2
… /news-events/fda-insight/fda-insight-vaccines-covid-19-part-2 … Listen (MP3, 14MB) Dr. Peter Marks returns … comprehensive discussion on vaccines as they relate to COVID-19. Find out more about “herd immunity,” Operation Warp …
FDA Insight: All About COVID-19 Testing
… /news-events/fda-insight/fda-insight-all-about-covid-19-testing … Listen (MP3, 9MB) Dr. Anand Shah, FDA's … Health, to discuss the basics of diagnostic tests for COVID-19. FDA Insight: Episode 2 – Transcript >> Anand Shah: …
COVID-19 Update for Food Operations Stakeholders Webinar
… od/workshops-meetings-webinars-food-and-dietary-supplements/covid-19-update-food-operations-stakeholders-webinar … The Food and … for Disease Control and Prevention (CDC) to provide a COVID-19 update for food operations stakeholders. The webinar …
Public Workshop on COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics - 09/28/2021
… /drugs/news-events-human-drugs/public-workshop-covid-19-lessons-learned-clinical-evaluation-therapeutics-09282021 … workshop is to share lessons learned from the Federal COVID-19 Response or Countermeasures Acceleration Groups (formerly …
FAQs on Emergency Use Authorizations (EUAs) for Medical Devices Related to COVID-19
… s-emergency-use-authorizations-euas-medical-devices-related-covid-19 … March 24, 2023 - The FDA has finalized two guidances: … Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for …
Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results
… navirus-covid-19-and-medical-devices/understanding-home-otc-covid-19-antigen-diagnostic-test-results … Español At-home over-the-counter (OTC) COVID-19 antigen tests, often referred to as rapid tests, …
FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine
… -announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine … Español Today, the U.S. Food and Drug … vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome …
Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised)
… guidance-documents/policy-evaluating-impact-viral-mutations-covid-19-tests-revised … March 24, 2023 - The FDA has finalized two … Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for …
FDA Will Follow The Science On COVID-19 Vaccines For Young Children
… /news-events/press-announcements/fda-will-follow-science-covid-19-vaccines-young-children … Español As schools around the … their children. Many parents have questions about COVID-19 and when vaccines will be available for children …
Doctor Selling COVID-19 “Cure” Sentenced to Prison
… t-and-criminal-investigations/press-releases/doctor-selling-covid-19-cure-sentenced-prison … Department of Justice Southern … by marketing what he described as a “miracle cure” for COVID-19, was sentenced today to 30 days of custody and one …
Actualización sobre el coronavirus (COVID-19): La FDA autoriza el uso de anticuerpos monoclonales para el tratamiento del COVID-19
… ress-announcements/actualizacion-sobre-el-coronavirus-covid-19-la-fda-autoriza-el-uso-de-anticuerpos-monoclonales-para … … e imdevimab se administren juntos para el tratamiento del COVID-19 leve a moderado en pacientes adultos y pediátricos (12 …
Pruebas de anticuerpos (serología) para el COVID-19: Información para pacientes y consumidores
… nd-medical-devices/pruebas-de-anticuerpos-serologia-para-el-covid-19-informacion-para-pacientes-y-consumidores … English El … vacunación. El virus SARS-CoV-2 es el virus que causa el COVID-19. Las pruebas de anticuerpos del SARS-CoV-2 detectan …
Update: COVID-19 Vaccine Booster Composition
… /vaccines-blood-biologics/update-covid-19-vaccine-booster-composition … June 30, 2022 FDA’s Vaccines … a change to the current vaccine strain composition of COVID-19 vaccine booster doses is necessary for the 2022 fall …
Doctor Selling COVID-19 “Cure” Pleads Guilty
… t-and-criminal-investigations/press-releases/doctor-selling-covid-19-cure-pleads-guilty … Department of Justice U.S. Attorney’s … profit from the pandemic by marketing a “miracle cure” for COVID-19, pleaded guilty in federal court today, admitting …
Remdesivir (Veklury) Approval for the Treatment of COVID-19—The Evidence for Safety and Efficacy
… potlight-cder-science/remdesivir-veklury-approval-treatment-covid-19-evidence-safety-and-efficacy … Under FDA law, approval of … (Veklury) for the treatment of patients hospitalized with COVID-19 met this legal and scientific standard. Background …
FDA Encourages Food and Agriculture Workers to Get Vaccinated Against Flu and COVID-19
… food-and-agriculture-workers-get-vaccinated-against-flu-and-covid-19 … en español Constituent Updates October 14, 2021 As influenza (flu) season approaches and COVID-19 remains a threat, protect yourself, your family, and …
North Carolina Woman Arrested for Selling Unapproved Remedies for Covid-19
… s/north-carolina-woman-arrested-selling-unapproved-remedies-covid-19 … Department of Justice U.S. Attorney’s Office District of … the Food Drug and Cosmetic Act by selling unapproved COVID-19 remedies over the internet, Acting United States …
FDA Insight: Drug Shortages and COVID-19
… /news-events/fda-insight/fda-insight-drug-shortages-and-covid-19 … Listen (MP3, 9MB) Valerie Jensen, the Associate … Dr. Shah for a discussion on drug shortages and how the COVID-19 pandemic can impact the drug supply chain. FDA …
Partnering with the European Union and Global Regulators on COVID-19
… /fda-voices/partnering-european-union-and-global-regulators-covid-19 … By: Anna Abram, Deputy Commissioner for Policy, … on many scientific and regulatory fronts as part of our COVID-19 response. Anna Abram What has helped drive this …
COVID-19 Supply Chain Update: Importation of Vital Food and Medical Products
… and public health officials across the country, to combat COVID-19. A critical part of the FDA’s work is ensuring the safety … our health care workers and hospitals need to battle COVID-19 come from overseas, which makes the FDA’s Office of …
Advancing the Science of Real-World Data to Address the COVID-19 Pandemic - 09/10/2020 - 09/10/2020
… /fda-grand-rounds/advancing-science-real-world-data-address-covid-19-pandemic-09102020-09102020 … About the Presentation: The … FDA continues to work around the clock to respond to the COVID-19 pandemic. As part of this effort, we recognize the …