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Tag: fda

Roche receives FDA clearance for BK virus quantitative test on cobas 6800/8800 Systems to support better care for transplant patients

• Immunocompromised transplant patients are at risk of major complications when infected with BK virus • cobas BKV test addresses critical need for hospitals and laboratories to have standardised and comparable results across institutions • New Breakthrough Device test expands Roche molecular test menu for transplant patients, enabling simultaneous testing of BK virus with Cytomegalovirus […]

Roche receives FDA Emergency Use Authorization for the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems

• First commercial test for fully automated high throughput systems to detect and differentiate SARS-CoV-2, influenza A virus and/or influenza B virus with a single sample • As COVID-19 and influenza infections can hardly be differentiated based on symptoms, healthcare professionals can confidently provide the right diagnosis and best course of treatment for patients • […]

Novartis Cosentyx® receives FDA approval for new indication to treat active non-radiographic axial spondyloarthritis

• FDA approval for Cosentyx® is based on the Phase III PREVENT trial, demonstrating efficacy in active non-radiographic axial spondyloarthritis (nr-axSpA), which is part of the axial spondyloarthritis (axSpA) disease spectrum • There are an estimated 2.7M people living with axial spondyloarthritis (axSpA) in the US; however, it remains significantly underdiagnosed1,2 • nr-axSpA approval is […]

FDA: Certain COVID-19 Serology/Antibody Tests Should Not Be Used

Letter to Clinical Laboratory Staff and Health Care Providers The U.S. Food and Drug Administration (FDA) recommends that clinical laboratories and health care providers stop using COVID-19 antibody tests that are listed on FDA’s “removed” test list, found on the FDA’s FAQs on Testing for SARS-CoV-2 webpage. The “removed” test list includes tests where significant […]

FDA approves olaparib for HRR gene-mutated metastatic castration-resistant prostate cancer

On May 19, 2020, the Food and Drug Administration approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals, LP) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone. Today, the FDA also approved FoundationOne CDx (Foundation Medicine, […]

FDA approves atezolizumab for first-line treatment of metastatic NSCLC with high PD-L1 expression

Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech Inc.) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ […]

US Contacts for Medical Devices During the COVID-19 Pandemic

The U.S. Food and Drug Administration (FDA) has published a new directory of email addresses for medical device questions during the COVID-19 pandemic. This directory includes contacts for questions about: • Emergency Use Authorizations (EUAs) • Device shortages • Enforcement policies and immediately in effect guidances for specific types of medical devices • Other topics, […]

FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%)

On May 15, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma […]

FDA approves ripretinib for advanced gastrointestinal stromal tumor

On May 15, 2020, the Food and Drug Administration approved ripretinib (QINLOCK, Deciphera Pharmaceuticals, LLC.), for adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Efficacy was evaluated in INVICTUS (NCT03353753), an international, multi-center, randomized (2:1), double-blind, placebo-controlled trial in 129 patients with […]

Questions about Using Thermal Imaging Systems during COVID-19

Q: Are thermal imaging systems effective for screening people for fevers in places like nursing homes, airports, and hospital emergency rooms? A: When using a thermal imaging system, it is important to assess whether the system will provide the intended results in high throughput areas. We understand that these devices are being used for initial […]

Thermal Imaging Systems and COVID-19

When used correctly, thermal imaging systems generally have been shown to accurately measure someone’s surface skin temperature without being physically close to the person being evaluated. Thermal imaging systems offer certain benefits in that other methods need a closer proximity or contact to measure temperature (for example, non-contact infrared thermometers or oral thermometers). Temperature-based screening, […]

FDA: Filtering Facepiece Respirators from China May Not Provide Adequate Protection

Letter to Health Care Providers The U.S. Food and Drug Administration (FDA) is concerned that certain filtering facepiece respirators (respirators) from China may not provide consistent and adequate respiratory protection to health care personnel exposed to COVID-19 based on additional filtration performance testing conducted by the National Institute for Occupational Safety and Health (NIOSH) – […]

Coronavirus FDA Q&A for Consumers

photo FDA

The FDA is working to address the coronavirus disease (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are answers to some frequently asked questions from consumers about possible treatments and Emergency Use Authorizations (EUAs): Q. Can disinfectant sprays or wipes be used on my skin, injected, inhaled, or ingested, […]

FDA – Donate COVID-19 Plasma

If you have fully recovered from COVID-19, you may be able to help patients currently fighting the infection by donating your plasma. Because you fought the infection, your plasma now contains COVID-19 antibodies. These antibodies provided one way for your immune system to fight the virus when you were sick, so your plasma may be […]

Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection

The U.S. Food and Drug Administration authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home […]

FDA Provides Flexibility to the Food Industry to Support Food Supply Chain and Meet Consumer Demand During COVID-19

4 photos collage: woman wearing face mask and rubber gloves while reading labels on packaged food items in grocery store, woman wearing face mask taping handwritten cary-out only sign on restaurant window, egg cartons stacked on grocery store shelf, outdoor sign advertising restaurant is open for drive thru pick up and mobile ordering By: Susan […]

FDA Issues New Policy for Telethermographic Systems During COVID-19

Today, the U.S. Food and Drug Administration (FDA) issued an immediately in effect guidance to help expand the availability of telethermographic systems used for body temperature measurements for triage use. The advantage of telethermographic systems for initial temperature assessment for triage use is the potential use in high throughput areas (such as airports, businesses, warehouses, […]

New Emergency Use Authorization (EUA) to Decontaminate Respirators

On April 9, 2020, the U.S. Food and Drug Administration granted an emergency use authorization to STERIS Corporation for the STERIS V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems using the STERIS N95 Decontamination Cycle (non-lumen cycle), which uses vaporized hydrogen peroxide to decontaminate compatible N95 or N95-equivalent respirators. Hydrogen peroxide sterilization is […]

FDA Provides Flexibility Regarding Menu Labeling Requirements for Chain Restaurants

…and Similar Retail Food Establishments During the COVID-19 Pandemic As a result of the COVID-19 pandemic, the U.S. Food and Drug Administration today released a guidance document, Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency, to provide temporary flexibility to […]

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