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FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

The Pharma Data

Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. director of the FDA’s Center for Devices and Radiological Health. Today, the U.S. for the next public health emergency.”.

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FDA Warns of Risks Associated with Non-Invasive Prenatal Screening Tests

The Pharma Data

Food and Drug Administration is warning the public of the risk of false results, inappropriate use and inappropriate interpretation of results with non-invasive prenatal screening (NIPS) tests, also called cell-free DNA tests or non-invasive prenatal tests (NIPT). director of the FDA’s Center for Devices and Radiological Health.

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FDA Provides Update on Recall of Certain Philips Respironics Breathing Assistance Machines

The Pharma Data

Food and Drug Administration is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. director of the FDA’s Center for Devices and Radiological Health. Today, the U.S.

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FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults

The Pharma Data

Food and Drug Administration (FDA) permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). Food and Drug Administration. .

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Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home

The Pharma Data

Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. director of FDA’s Center for Devices and Radiological Health. Food and Drug Administration. SILVER SPRING, Md. , .

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FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse

The Pharma Data

Food and Drug Administration authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse. director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health.