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FDA to Discuss COVID-19’s Impact on Medical Product Operations at SBIA REdI Annual Conference
… Acting Commissioner of Food and Drugs In the face of the COVID-19 pandemic, the U.S. Food and Drug Administration has worked … an overview of our regulatory operations during COVID-19. The annual event, which will run July 19-23, 2021, marks …
SBIA Webinar: Conducting Clinical Trials During the COVID-19 Public Health Emergency - 04/30/2020 - 04/30/2020
… -human-drugs/sbia-webinar-conducting-clinical-trials-during-covid-19-public-health-emergency-04302020-04302020 … View Recording … View Slides ABOUT THIS WEBINAR FDA recognizes that the COVID-19 public health emergency may impact the conduct of …
Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19
… /news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-drug-combination-treatment-covid-19 … Español Today, the U.S. Food and Drug Administration …
Actualización sobre el Coronavirus (COVID-19): La FDA toma medidas adicionales sobre el uso de una dosis de refuerzo para las vacunas contra el COVID-19
… ents/press-announcements/actualizacion-sobre-el-coronavirus-covid-19-la-fda-toma-medidas-adicionales-sobre-el-uso-de-una … … el uso de una dosis de refuerzo para las vacunas contra el COVID-19 en poblaciones elegibles. La agencia está …
La FDA toma medidas para aumentar la disponibilidad de la vacuna contra el COVID-19
… idas-para-aumentar-la-disponibilidad-de-la-vacuna-contra-el-covid-19 … English Después de una cuidadosa revisión y … suministro críticamente necesario de la vacuna contra el COVID-19 de Janssen (Johnson & Johnson). La agencia anunció …
COVID-19 Update: FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card
… and does not need the use of an analyzer. “This new COVID-19 antigen test is an important addition to available tests … test has been authorized for use in patients suspected of COVID-19 by their healthcare provider within seven days of …
FDA Issues Federal Register Notice to Announce Status of COVID-19 Guidance Documents When Public Health Emergency Expires
… -updates/fda-issues-federal-register-notice-announce-status-covid-19-guidance-documents-when-public-health … Constituent Update … the Public Health Emergency (PHE) will impact the agency’s COVID-19 guidance documents. On January 30, President Biden …
Entendiendo los resultados de la prueba diagnóstica de antígeno COVID-19 en casa de venta libre
… ndiendo-los-resultados-de-la-prueba-diagnostica-de-antigeno-covid-19-en-casa-de-venta-libre … English Las pruebas de antígenos del COVID-19 de venta libre (OTC, por sus siglas en inglés) …
Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home
… ouncements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-self-testing-home … Español Today, the U.S. Food and … issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that …
Tìm hiểu thuật ngữ quy định về các loại thuốc phòng ngừa và điều trị COVID-19 tiềm năng
… thuat-ngu-quy-dinh-ve-cac-loai-thuoc-phong-ngua-va-dieu-tri-covid-19-tiem-nang … English Các nhà khoa học liên tục nghiên cứu … các loại thuốc tiềm năng trong việc phòng ngừa và điều trị COVID-19. Ngôn ngữ được sử dụng để mô tả các loại thuốc tiềm …
Biết Các Lựa Chọn Điều Trị Của Bạn cho COVID-19
… ers/consumer-updates/biet-cac-lua-chon-dieu-tri-cua-ban-cho-covid-19 … English Ngày nay bạn có một số lựa chọn điều trị để ngăn … phải nhập viện và các biến chứng nghiêm trọng khác của COVID-19. Cơ Quan Quản lý Thực phẩm và Dược phẩm Hoa Kỳ đã …
Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19
… vid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19 … Español Today, the U.S. Food and Drug Administration … for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age …
La FDA sigue tomando pasos importantes para garantizar la calidad, la seguridad y la eficacia de las vacunas autorizadas contra el COVID-19
… los productos médicos, incluyendo las vacunas contra el COVID-19, cumplan las normas de calidad, seguridad y eficacia de la … de fabricación propuesta para la vacuna contra el COVID-19 de Johnson & Johnson. Como Johnson & Johnson anunció …
At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative Results: FDA Safety Communication
… to the need for repeat testing following a negative COVID-19 test result on COVID-19 antigen tests -- revising the emergency use …
Norfolk Man Charged with Price Gouging N95 Masks in Early Months of COVID-19 Pandemic
… es/norfolk-man-charged-price-gouging-n95-masks-early-months-covid-19-pandemic … Department of Justice U.S. Attorney’s Office … facepiece respirators (N95 masks) at the start of the COVID-19 pandemic. Jason Colantuoni, 35, was charged by an …
FDA Offers Assurance About Food Safety and Supply for People and Animals During COVID-19
… ance-about-food-safety-and-supply-people-and-animals-during-covid-19 … By: Frank Yiannas, Deputy Commissioner for Food Policy … Watch and download FDA’s " What You Need to Know: Food and COVID-19 " public service announcement with Frank Yiannas …
Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine
… is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional … Inc. submitted data to the FDA to demonstrate that their COVID-19 vaccine remains stable after storage of the …
Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System
… 19-update-fda-issues-emergency-use-authorization-symbiotica-covid-19-self … Español The U.S. Food and Drug Administration today … an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first …
Doctor Selling COVID-19 “Cure” Charged with Lying to U.S. Customs, Stealing Employee’s Identity
… criminal-investigations/press-releases/doctor-selling-covid-19-cure-charged-lying-us-customs-stealing-employees-identity … crimes arising from his business venture selling COVID-19 “treatment kits,” which he advertised to one potential …
Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate
… -19-update-fda-announces-advisory-committee-meeting-discuss-covid-19-vaccine … The U.S. Food and Drug Administration has … the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with …
Initial Results of Near Real-Time Safety Monitoring of COVID-19 Vaccines in Persons Aged 65 Years and Older
… -biologics/initial-results-near-real-time-safety-monitoring-covid-19-vaccines-persons-aged-65-years-and-older … Vaccines … The … any new causal relationships between the Pfizer-BioNTech COVID-19 Vaccine and potential adverse events of special …
Remarks by Dr. Hahn to the National Academy of Medicine Town Hall on the COVID-19 Vaccine - 12/04/2020
… ficials/remarks-dr-hahn-national-academy-medicine-town-hall-covid-19-vaccine-12042020 … Thank you for being here today for this … HHS colleagues would agree, working together tirelessly on COVID-19 has further strengthened our already close working …
FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19
… te-interactive-evaluations-oversight-drug-facilities-during-covid-19 … Additional Information Today, the U.S. Food and Drug … and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency .” This guidance describes …
CDRH Statement on Emergency Use Authorization of Lucira Health’s COVID-19 & Flu Home Test
… s/cdrh-statement-emergency-use-authorization-lucira-healths-covid-19-flu-home-test … FOR IMMEDIATE RELEASE March 7, 2023 The … the emergency use authorization (EUA) of Lucira Health’s COVID-19 & Flu Home test. As the standard for EUA is …
FDA’s Generic Drug Program in 2020 Helped Ensure Availability of High-Quality, Affordable Drugs Amid COVID-19
… lped-ensure-availability-high-quality-affordable-drugs-amid-covid … By: Sally Choe, Ph.D., Director, Office of Generic … generic drug program moved steadily forward even as the COVID-19 pandemic presented additional complexities, resulting in …