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

The Pharma Data

NOVEMBER 6, 2020

director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. This device was studied in a 30-day randomized, sham-controlled trial of 70 patients. Patients in the sham group wore the device, but no vibratory stimulation was provided.

Marketing

Marketing Production Radiology Cosmetics

FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse

The Pharma Data

FEBRUARY 23, 2022

director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health. The safety and efficacy of the One Male Condom was studied in a clinical trial comprised of 252 men who have sex with men and 252 men who have sex with women.

Marketing

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Clinical Research Informer

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

FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse

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