Page 4 - Tim Stenzel News Today

The agency's announcement Tuesday is aimed at making it easier to screen Americans returning to school and work, senior FDA regulators said.

The slow process to getting rapid COVID-19 tests approved by the FDA Published: February 26, 2021 5:31 PM EST Updated: February 26, 2021 6:05 PM EST Recommended A top national scientist speaks out against the FDA, saying the agency is too slow to push out new COVID-19 tests leading to outbreaks and costing us lives. Now, the FDA responds. When the pandemic began, Owen Kaye-Kauderer and his team knew how to help. Kaye-Kauderer is the Cofounder and Chief Business Officer of Detect. “That meant ...

POLITICO Get the Prescription Pulse newsletter Email Sign Up By signing up you agree to receive email newsletters or updates from POLITICO and you agree to our privacy policy and terms of service. You can unsubscribe at any time and you can contact us here. This sign-up form is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. Presented by Coalition for Affordable Prescription Drugs With Emily Martin — Congress waits on FDA pick as Senate readies for the first ...

Biden health team hatches new vaccine strategy as variant threat builds POLITICO 2/5/2021 © Michael Ciaglo/Getty Images Pharmacy technicians prepare doses of the Covid-19 vaccine. The Food and Drug Administration is preparing to release new standards for Covid-19 vaccine booster shots, tests and drugs in the coming weeks — all aimed at preparing the country to beat back fast-spreading virus variants that are less susceptible to existing shots. The agency confirmed Thursday that it plans ...

Copy shortlink: The U.S. Food and Drug Administration is alerting lab managers that several COVID-19 tests, including one used in Minnesotas free public testing, carry a slight risk of returning inaccurate results because of recent genetic mutations in the virus. But theres an upside. Thermo Fisher Scientific, which makes the TaqPath COVID test used at community testing sites across the state, says the test not only remains accurate, but it may offer an important clue th...

Link Copied The Department of Health and Human Services is paying a private firm to review the accuracy of some Covid-19 tests — the latest example of the department’s political leadership attempting to bypass scientists at the Food and Drug Administration. The idea behind the last-minute contract, announced days before President Donald Trump leaves office, is that HHS would use the review to issue emergency use authorizations for the tests without input from FDA. It comes as the health dep...

Dive Brief: FDA on Wednesday said it is working with SARS-CoV-2 test developers to determine potential impact on the efficacy of coronavirus diagnostics as a coronavirus variant first identified in the U.K. has now been found in the U.S. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, told Wednesdays virtual town hall for test developers the agency is trying to assess whether existing coronavirus tests are able to properly detect new COVID-19 variant...

This story provided by Ohio Northern University HealthWise Pharmacy. (RxWiki News) The US Food and Drug Administration (FDA) approved a new test that can detect neutralizing antibodies from a past SARS-CoV-2 infection. Its the first test of its kind. The FDA has granted more than 50 antibody (serology) tests an emergency use authorization (EUA). This newly approved test, called cPass SARS-CoV-2 Neutralization Antibody Detection Kit, was one of them. But this test is different. This test can det...