Aug 6th, 2020 - For Immediate Release: August 06, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On August 4, the FDA issued Emergency Use Authorizations (EUAs) for ventilator-related devices to: Lombardi Undersea, for its Subsalve Oxygen Treatment Hood, which is a patient interface intended for helmet-based Non-In...

Aug 5th, 2020 - For Immediate Release: August 05, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA issued its first warning letter to New Life International and its second warning letter to Fishman Chemical of North Carolina, LLC, both of which distribute chloroquine phosphate products intended to treat disea...

Aug 4th, 2020 - For Immediate Release: August 04, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: FDA has updated its COVID-19 Drug Shortages Response webpage to provide information regarding in-use time for certain drugs during the COVID-19 public health emergency. “In-use time” is the maximum amount of time that c...

Aug 4th, 2020 - For Immediate Release: July 31, 2020 Español Today, the U.S. Food and Drug Administration authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in the individual’s blood. Both tests from Siemens, the ADVIA Centaur COV2G and Atellica IM COV2G, are what are known as “semi-quantitative” tests, meaning that they do not display a precise measuremen...

Aug 4th, 2020 - For Immediate Release: July 31, 2020 English Hoy, la Administración de Alimentos y Medicamentos de los EE.UU. autorizó las primeras dos pruebas serológicas para el COVID-19 que muestran la cantidad estimada de anticuerpos presentes en la sangre de una persona. Ambas pruebas de Siemens, ADVIA Centaur COV2G y Attelica COV2G, son lo que se conoce como pruebas “semicuantitativas”, lo que significa ...

Aug 4th, 2020 - For Immediate Release: April 08, 2020 English La Administración de Alimentos y Medicamentos de los EE.UU. (FDA, por sus siglas en inglés) emitió una carta de advertencia a una empresa que está comercializando productos fraudulentos y nocivos conocidos como “Miracle Mineral Solution” (solución mineral milagrosa) para la prevención y tratamiento de la “enfermedad del nuevo coronavirus 2019” (COVI...

Aug 3rd, 2020 - For Immediate Release: August 03, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA issued emergency use authorizations (EUAs) to Siemens for its ADVIA Centaur SARS-CoV-2 IgG (COV2G) and Atellica IM SARS-CoV-2 IgG (COV2G) tests, which are the first COVID-19 serology tests that display an estima...

Aug 3rd, 2020 - Phase III clinical trials to evaluate mRNA-1273, an investigational vaccine against COVID-19 developed by the National Institutes of Health (NIH) and drug developer Moderna, have enrolled 30,000 adult volunteers. It is the largest study of a COVID-19 vaccine so far, and the vaccine is one of several candidates being studied worldwide. Testing will be conducted at approximately 89 clinical resea...

Aug 3rd, 2020 - A report from Medicare’s trustees in April 2020 estimated that the program’s Part A trust fund, which subsidizes hospital and other inpatient care, would begin to run out of money in 2026. At the time, the trustees cautioned that their calculations did not include the potential impact of COVID-19. Now, experts have conducted follow-up projections on the viability of the Part A trust to account ...

Aug 1st, 2020 - Researchers from Massachusetts General Hospital in Boston have identified several markers at presentation that predict coagulation-associated complications in patients with COVID-19: elevated D-dimer, C-reactive protein (CRP), platelet count, and erythrocyte sedimentation rate. The findings were published in Blood by lead author Hanny Al Samkari, MD, and his colleagues. Incorporating these mark...

Aug 1st, 2020 - The White House has announced the restriction of several categories of work visas for non-American citizens, in response to high unemployment levels following the coronavirus pandemic and subsequent lockdown. Following the announcement, experts expressed concern about how the suspensions would affect the science and technology industries. The new restrictions follow orders issued in June that s...

Aug 1st, 2020 - The FDA has released new guidance regarding statistical considerations for clinical trials affected by the COVID-19 pandemic, with the aim of maintaining integrity of trial data. “To help ensure that the trial will provide interpretable findings with correct statistical quantification of uncertainty, this guidance addresses statistical considerations for proposed changes to trial conduct due to...

Jul 31st, 2020 - For Immediate Release: July 31, 2020 The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic: As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to one company for selling fraudulent COVID-19 related products. The company, Vapore, LLC, dba Mypurmist, se...

Jul 31st, 2020 - For Immediate Release: July 31, 2020 Statement From: Statement Author Leadership Role Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D. Leadership Role Director - Center for Food Safety and Applied Nutrition (CFSAN) Susan T. Mayne Ph.D. Today, the U.S. Food and Drug Administration is announcing that the manufacturers of certain per- and polyfluoroalkyl substance...

Jul 30th, 2020 - For Immediate Release: July 30, 2020 The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic: On July 29, FDA updated its “Food Safety and the Coronavirus Disease” webpage of Questions and Answers (Q&A). The Center for Food Safety and Nutrition added a new Q&A item, titled “What do U.S. exporters of FDA-regulated food products ...

Jul 30th, 2020 - For Immediate Release: July 29, 2020 Español Today, the U.S. Food and Drug Administration posted a new template for commercial developers to help them develop and submit emergency use authorization (EUA) requests for COVID-19 diagnostic tests that can be performed entirely at home or in other settings besides a lab, such as offices or schools, and that could be available without a prescription....

Jul 30th, 2020 - For Immediate Release: July 29, 2020 English Hoy, la Administración de Alimentos y Medicamentos de los EE.UU. (FDA, por sus siglas en inglés) publicó un  nuevo modelo (en inglés) para los desarrolladores comerciales para ayudarles a desarrollar y presentar sus solicitudes de autorización de uso de emergencia (EUA, por sus siglas en inglés) para las pruebas de diagnóstico del COVID-19 que pueden...

The FDA monitors reports of adverse events and other problems with medical devices and alerts the public when needed to ensure proper use of devices and protect the health and safety of patients and users. The FDA is issuing this safety communication to provide information to patients and health care providers about the risk associated with using deep brain stimulation (DBS) devices for Parkins...

Jul 29th, 2020 - For Immediate Release: July 29, 2020 The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic: On July 28, the FDA updated the Molecular Diagnostic templates. The Molecular Diagnostic templates include recommendations for laboratories and commercial manufacturers who may use the templates to help facilitate the preparation and s...

Jul 29th, 2020 - For Immediate Release: July 24, 2020 English Hoy, la Administración de Alimentos y Medicamentos de los EE.UU. (FDA, por sus siglas en inglés) volvió a emitir la autorización de uso de emergencia (EUA, por sus siglas en inglés) para la Prueba LabCorp COVID-19 RT-PCR para incluir dos nuevas indicaciones para su uso: para personas que no tienen síntomas del COVID-19 o que no tienen razón para sosp...