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FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

The Pharma Data

director of the FDA’s Center for Devices and Radiological Health. The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position 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

director of the FDA’s Center for Devices and Radiological Health. All NIPS tests on the market today are offered as laboratory developed tests (LDTs). Without proper understanding of how these tests should be used, people may make inappropriate health care decisions regarding their pregnancy.

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

The Pharma Data

director of the FDA’s Center for Devices and Radiological Health. “We An FDA investigator’s list of examination compliances doesn’t constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its enforcing regulations.

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

The Pharma Data

director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. PTSD is a disorder that develops in some people who have experienced a shocking, scary, or dangerous event. . .

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

The Pharma Data

director of FDA’s Center for Devices and Radiological Health. “We look forward to proactively working with test developers to support the availability of more at-home test options.” ” An important component to successful at-home testing is the ability to efficiently track and monitor results.

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FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse

The Pharma Data

director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health. Furthermore, this authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations.