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The Critical Role of Health Care Professionals During the COVID-19 Pandemic - 08/10/2020
… da-officials/critical-role-health-care-professionals-during-covid-19-pandemic-08102020 … (Remarks as prepared for delivery) … to have the opportunity today to speak with you about COVID-19, the FDA’s role in responding to this public health …
FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines
… nt-steps-ensure-quality-safety-and-effectiveness-authorized-covid-19-vaccines … Español The U.S. Food and Drug Administration … the agency to ensure that all medical products, including COVID-19 vaccines, meet the agency’s standards for quality, …
Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds
… rus-covid-19-update-fda-expands-eligibility-pfizer-biontech-covid-19-booster-dose-16-and-17 … Español Today, the U.S. Food and … emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster …
Actualización sobre el coronavirus (COVID-19): La FDA autoriza la primera prueba diagnóstica para personas que no sepan o sospechen que estén infectadas por el COVID-19
… ents/press-announcements/actualizacion-sobre-el-coronavirus-covid-19-la-fda-autoriza-la-primera-prueba-diagnostica-para … … (EUA, por sus siglas en inglés) para la Prueba LabCorp COVID-19 RT-PCR para incluir dos nuevas indicaciones para su …
FDA Issues Final Guidances to Assist with Transition Plans for COVID-19-Related Medical Devices
… d-events/fda-issues-final-guidances-assist-transition-plans-covid-19-related-medical-devices … The following is attributed to … to support the response to the Coronavirus Disease 2019 (COVID-19) pandemic. CDRH finalized these transition guidances …
Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19
… ovid-19-update-fda-expedites-review-diagnostic-tests-combat-covid-19 … Español The U.S. Food and Drug Administration has been … flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA’s regulations have not …
FDA Insight: Advisory Committee on COVID-19 Vaccines
… /news-events/fda-insight/fda-insight-advisory-committee-covid-19-vaccines … Vaccines … Listen (MP3, 9MB) Dr. Peter … returns for his third episode to provide an update on COVID-19 vaccines and to discuss the upcoming Vaccines and …
Elastomeric Respirator Innovations Play a Critical Role in Response to COVID-19
… stomeric-respirator-innovations-play-critical-role-response-covid-19 … By: Suzanne Schwartz, M.D., M.B.A., Director, Office of … Center for Devices and Radiological Health Since the COVID-19 public health emergency was declared over a year …
Justice Department Announces Results of Nationwide COVID-19 Fraud Enforcement Action
… ss-releases/justice-department-announces-results-nationwide-covid-19-fraud-enforcement-action … U.S. Department of Justice FOR … 23, 2023 Department Also Announces the Launch of Two New COVID-19 Fraud Strike Forces The Justice Department announced …
Rare Disease Therapy Development and Access Remain Top FDA Priorities During COVID-19
… apy-development-and-access-remain-top-fda-priorities-during-covid-19 … By: Patrizia Cavazzoni, M.D., Acting Director, Center … ever as these patients are among the most vulnerable to COVID-19, either directly or indirectly. Many rare disease …
La FDA autoriza una dosis de refuerzo de la vacuna contra el COVID-19 de Pfizer-BioNTech para determinadas poblaciones
… a-fda-autoriza-una-dosis-de-refuerzo-de-la-vacuna-contra-el-covid-19-de-pfizer-biontech-para … English Hoy, la Administración … (EUA, por sus siglas en inglés) de la vacuna contra el COVID-19 de Pfizer-BioNTech para permitir el uso de una dosis …
FDA Permits Marketing of First COVID-19 At-Home Test Using Traditional Premarket Review Process
… news-events/press-announcements/fda-permits-marketing-first-covid-19-home-test-using-traditional-premarket-review-process … … Administration granted marketing authorization for the Cue COVID-19 Molecular Test. The product is a molecular nucleic …
Court Prohibits Dallas Wellness Center from Touting ‘Ozone Therapy’ as COVID-19 Treatment
… ourt-prohibits-dallas-wellness-center-touting-ozone-therapy-covid-19-treatment … Department of Justice U.S. Attorney’s Office … center in Dallas from offering unproven treatments for COVID-19, U.S. Attorney Erin Nealy Cox announced today. In a …
Maryland U.S. Attorney’s Office Seizes Domain Name Falsely Purporting to Provide COVID-19 Vaccines
… orneys-office-seizes-domain-name-falsely-purporting-provide-covid-19-vaccines-0 … Department of Justice U.S. Attorney’s Office … Thursday, May 20, 2021 Website Falsely Purported to Sell COVID-19 Vaccines Online and Provide Same-Day Worldwide …
Conozca sus opciones de tratamiento contra el COVID-19
… or-en-espanol/conozca-sus-opciones-de-tratamiento-contra-el-covid-19 … English Hoy en día tiene varias opciones de tratamiento … la hospitalización y otras complicaciones graves del COVID-19. La Administración de Alimentos y Medicamentos de …
Unleashing the Power of FDA Data to Support COVID-19 Vaccine Distribution to Food and Agriculture Workers
… /news-events/fda-voices/unleashing-power-fda-data-support-covid-19-vaccine-distribution-food-and-agriculture-workers … By: … that the agency created to help inform our response to the COVID-19 pandemic. Now, through an important partnership …
FDA Insight: Personal Protective Equipment and COVID-19
… s/fda-insight/fda-insight-personal-protective-equipment-and-covid-19 … Listen (MP3, 16MB) Dr. Shah welcomes Dr. Suzanne … and its critical role in helping to reduce the spread of COVID-19. FDA Insight: Episode 19 – Transcript >> Anand Shah: …
Updated Information for Blood Establishments Regarding the COVID-19 Pandemic and Blood Donation
… iologics/updated-information-blood-establishments-regarding-covid-19-pandemic-and-blood-donation … January 11, 2022 FDA … agencies to monitor the coronavirus disease 2019 (COVID-19) pandemic caused by the virus, SARS-CoV-2. …
FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including Newborns
… onoclonal-antibodies-treatment-and-post-exposure-prevention-covid-19 … Español Today, the U.S. Food and Drug Administration … together for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including …
Using Home-Use Blood Glucose Meters in Hospitals During the COVID-19 Pandemic
… evices/using-home-use-blood-glucose-meters-hospitals-during-covid-19-pandemic … The FDA recognizes that home-use blood glucose … used by patients with diabetes who are hospitalized due to COVID-19 or by those who reside in long-term care facilities …
Actualización sobre el coronavirus (COVID-19): La FDA toma medidas para ayudar a facilitar el desarrollo oportuno de vacunas seguras y eficaces contra el COVID-19
… ress-announcements/actualizacion-sobre-el-coronavirus-covid-19-la-fda-toma-medidas-para-ayudar-facilitar-el-desarrollo … … oportuno de vacunas seguras y eficaces para prevenir el COVID-19 proporcionando una guía (en inglés) con recomendaciones …
FDA In Brief: FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data
… fda-brief/fda-brief-fda-updates-emergency-use-authorization-covid-19-convalescent-plasma-reflect-new-data … February 4, 2021 … a revision of the Emergency Use Authorization (EUA) for COVID-19 convalescent plasma as a result of our evaluation of …
Coronavirus (COVID-19) Update: FDA updates on surveillance inspections during COVID-19
… covid-19-update-fda-updates-surveillance-inspections-during-covid-19 … During COVID-19, the U.S. Food and Drug Administration will continue …
Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19
… update-fda-continues-accelerate-development-novel-therapies-covid-19 … As part of the Trump Administration’s all-hands-on-deck … across public, academic and private sectors to combat the COVID-19 pandemic, the U.S. Food and Drug Administration …
FDA Insight: Clinical Trials and Treatments for COVID-19
… ents/fda-insight/fda-insight-clinical-trials-and-treatments-covid-19 … Listen (MP3, 15MB) Dr. Patrizia Cavazzoni, the … in-depth discussion on clinical trials and treatments for COVID-19. A list of clinical trials are available at …