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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. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. 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. While LDTs are medical devices under the Federal Food, Drug, and Cosmetic Act, the FDA has had a general policy of enforcement discretion for most LDTs since the Medical Device Amendments were enacted in 1976.

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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. . . SOURCE U.S.

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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. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. . .

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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. The FDA’s authorization of a condom that is specifically indicated, evaluated and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse,” said Courtney Lias, Ph.D.,