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Actualización sobre el coronavirus (COVID-19): La FDA autoriza segunda dosis de refuerzo de dos vacunas contra el COVID-19 para personas mayores e inmunocomprometidas
… una segunda dosis de refuerzo de las vacunas contra el COVID-19 de Pfizer-BioNTech o Moderna para personas mayores y … segunda dosis de refuerzo de una vacuna de ARNm contra el COVID-19 mejora la protección contra el COVID-19 grave y no …
FDA In Brief: FDA Advises Against Use of SARS-CoV-2 Antibody Test Results to Evaluate Immunity or Protection From COVID-19, Including After Vaccination
… should not be used to evaluate immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination. The authorized vaccines for prevention …
Tulare County Man Indicted for Falsely Marketing Herbal Mixtures as FDA-Approved Treatment for COVID-19
… “Emergency D-Virus Plan of Care,” which he claimed treated COVID-19. In materials posted on the companies’ websites and … conditions and had specifically been approved to treat COVID 19. In reality, the FDA has never approved any Golden …
Actualización sobre el coronavirus (COVID-19): La FDA autoriza una combinación de medicamentos para el tratamiento del COVID-19
… en combinación con remdesivir, para el tratamiento de COVID-19 sospechado o confirmado por un laboratorio en adultos … En un ensayo clínico de pacientes hospitalizados con COVID-19, se demostró que baricitinib, en combinación con …
FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation
… aid the response efforts and ease the economic impact of COVID-19. The legislation will help all of us at the FDA deliver … additional $80 million in funding to continue the Agency’s COVID-19 response efforts, including the development of …
FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review
… pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted and use of the … in individuals following administration of the Janssen COVID-19 Vaccine. During the pause, medical and scientific …
Actualización sobre el coronavirus (COVID-19): La FDA emite una Autorización de Uso Urgente para posible tratamiento del COVID-19
… de presuntos casos o casos confirmados por laboratorio del COVID-19 en adultos y niños hospitalizados con la enfermedad grave. … remdesivir para tratar a personas hospitalizadas con el COVID-19, se demostró en un ensayo clínico que el medicamento …
Actualización sobre el coronavirus (COVID-19): La FDA autoriza el primer tratamiento antiviral oral contra el COVID-19
… para el tratamiento de la enfermedad del coronavirus (COVID-19) de leve a moderada, en adultos y pacientes pediátricos … y que tienen un alto riesgo de enfermar gravemente de COVID-19, incluyendo la hospitalización o la muerte. Paxlovid …
SD Biosensor Recalls STANDARD Q COVID-19 Ag Home Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results
… Recalled Product Product Name: SD Biosensor STANDARD Q COVID-19 Ag Home Test Product Codes and Lot Numbers: See recall … January 31, 2022 Device Use The SD Biosensor STANDARD Q COVID-19 Ag Home Test uses a nasal swab sample to detect …
Coronavirus (COVID-19) Update: FDA takes steps to streamline path for COVID-19 screening tools, provides information to help groups establishing testing programs
… an important cornerstone of our nation’s fight against COVID-19. This includes schools, workplaces, communities and other … individuals who do not have known or suspected exposure to COVID-19 in order to make individual decisions, such as …
Coronavirus (COVID-19) Update: FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase the Number of Vaccine Doses Available
… the number of doses per vial available for the Moderna COVID-19 Vaccine. The first revision clarifies the number of doses … of these revisions positively impact the supply of Moderna COVID-19 Vaccine, which will help provide more vaccine doses …
SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA
… communication, Do Not Use Skippack Medical Lab SARS-CoV-2 COVID-19 Tests . Recalled Product Product Names: Skippack Medical … Lab SARS-CoV-2 Antigen Rapid Test Kit, Lateral Flow COVID 19 Rapid Antigen Test, SKIPPACK COVID-19 Antigen Home …
Pruebas de antígenos del COVID-19 realizadas en casa - Tome medidas para reducir el riesgo de falsos negativos: Comunicado de seguridad de la FDA
… un resultado negativo en las pruebas de antígenos del COVID-19 que consistió en revisar las autorizaciones de uso de … siglas en inglés) de todas las pruebas de antígenos del COVID-19 autorizadas el 1 de noviembre de 2022. Para más …
Conspiracy and Fraud Charges Added Against Operator of Central California Bio-Lab and His Partner in Connection with Sale of Millions of Dollars in COVID-19 Test Kits
… indicted for distributing adulterated and misbranded COVID-19 test kits in violation of the federal Food, Drug, and … Fresno and Reedley along with Zhu. UMI and PBI distributed COVID-19, pregnancy, and other types of test kits. According …
Coronavirus (COVID-19) Update: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of a COVID-19 Treatment Authorized for Emergency Use
… use authorization for the treatment of hospitalized COVID-19 patients with severe disease. Based on a recently … important information about using remdesivir to treat COVID-19 patients,” said Patrizia Cavazzoni, M.D., acting …
La FDA permite la comercialización de la primera prueba de COVID-19 para el hogar mediante el proceso tradicional de revisión previa a la comercialización
… de comercialización para la prueba molecular de COVID-19 de Cue. El producto es una prueba molecular de … superiores. Esta es la primera prueba de venta libre de COVID-19 para hacerse en el hogar que recibe autorización de …
The Real-World Effectiveness of COVID-19 Vaccines in the Pediatric Population Across the University of California Health System
… virus (SARS-CoV-2) infection, much is still unknown about COVID-19 and the impact of vaccination on disease severity and … development of SARS-CoV-2 vaccines for protection against COVID-19 was rapid as compared to historical timelines, …
La FDA toma medidas para ampliar el uso del tratamiento para pacientes ambulatorios con COVID-19 de riesgo leve a moderado
… ambulatorios para el tratamiento de la enfermedad por COVID-19 de riesgo leve a moderado. Esto proporciona otra opción de … de hoy refuerzan el arsenal terapéutico para tratar el COVID-19 y responder al aumento de la variante ómicron", …
Florida Family Indicted for Selling Toxic Bleach as Fake “Miracle” Cure for Covid-19 and Other Serious Diseases, and for Violating Court Orders
… Solution,” a toxic industrial bleach, as a cure for COVID-19, cancer, Alzheimer’s, diabetes, autism, malaria, … claimed that ingesting MMS could treat, prevent, and cure COVID-19, according to the charges. The FDA, however, had not …
Celltrion USA Recalls Certain Point of Care Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life
… death. Recalled Product Product Name: Celltrion DiaTrust COVID-19 Ag Rapid Test Product Code: 83QKP Lot Numbers: See Recall … 2022 Device Use The Point of Care (POC) Celltrion DiaTrust COVID-19 Ag Rapid Test is intended to detect the presence of …
Universal Meditech Inc. Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA
… communication Do Not Use Skippack Medical Lab SARS-CoV-2 COVID-19 Tests . Recalled Product Product Names: Skippack Medical … Universal Meditech Inc. is recalling Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests (Colloidal Gold) because …
Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.’s COVID-19 Vaccine Candidate
… the request for emergency use authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc. “A public discussion by … of safety and effectiveness of Janssen Biotech Inc.’s COVID-19 vaccine will help ensure that the public has a clear …
Actualización sobre el COVID-19: La FDA autoriza la primera prueba diagnóstica donde los resultados se pueden leer directamente de la tarjeta de prueba
… uso de un analizador. “Esta nueva prueba de antígeno del COVID-19 es una adición importante a las pruebas ya disponibles … ha sido autorizada para uso en pacientes con sospecha del COVID-19 por su proveedor de atención médica dentro de los …
E25Bio Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results
… (Include the following information) Product Names: E25Bio COVID-19 Direct Antigen Rapid Test; Trade Name: E25Bio SARS-CoV-2 … Initiated by Firm: January 27, 2022 Device Use The E25Bio COVID-19 Direct Antigen Rapid Test is used to detect proteins …
Actualización sobre el coronavirus (COVID-19): La FDA autoriza la primera prueba de diagnóstico de COVID-19 que utiliza muestras de aliento
… siglas en inglés) para la primera prueba de diagnóstico de COVID-19 que detecta compuestos químicos en muestras de aliento … que se está realizando con las pruebas de diagnóstico de COVID-19", dijo el Dr. Jeff Shuren, director del Centro de …