During the manufacturing facility inspection, the FDA obtained additional information regarding the silicone-based foam used in a device outside the United States that failed one safety test for the release of VOCs.
The company intends to complete the repair and replacement programs within approximately 12 months.
The designation was based, in part, on early phase and preliminary clinical data that indicates Takeda’s investigational oral orexin agonist may demonstrate substantially improved objective and subjective measurements of daytime wakefulness in NT1 patients.
This randomized controlled trial will take place at approximately 20 sites across the United States and will enroll a maximum of 150 adult patients with moderate to severe OSA who do not achieve results from a traditional CPAP machine or have declined its use.
Telemedicine appointments and drop-shipped home sleep tests surge during the pandemic. Some predict these changes may be incorporated into a new normal.
Kenneth A. Mogell, DMD, DABDSM, helps many people on Medicare treat their sleep apnea with oral appliances.
An investigation began in January 2020 when VAMC reported two bronchoscopes went missing from the hospital.
The commission investigation has found that for several years, this “pay-for-delay” agreement eliminated Teva as a competitor and allowed Cephalon to continue charging high prices even if the main modafinil patent had long expired.
An investigation found the train engineer had undiagnosed sleep apnea, and a National Transportation Safety Board investigation faulted NJ Transit for not following its sleep apnea testing guidelines, reports NBC 4 New York.