Regulatory News

Regulatory News

FDA Warns About Doral: Sales Aid Misleading

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In a letter dated 10/29/14, the US Food & Drug Administration’s Office of Prescription Drug Promotion (OPDP) warned insomnia therapy pill manufacturer Sciecure Pharma Inc that its misleading sales aid is not acceptable. Sciecure Pharma manufactures Doral (quazepam) Tablets for oral use C-IV.

narcolepsy cyclical

Regulatory News

Narcolepsy Patients Report Cyclical Nature to Symptoms

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Some narcolepsy patients notice a cyclical pattern to their symptoms, noticing a worsening during certain seasons or specific times of the month, according to the Food & Drug Administration (FDA) “Voice of the Patient” report. The cyclical nature particularly relates to their ability to sleep.

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telemedicine laws

Regulatory News

Sleep Telemedicine Legal Tips and Traps

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Telemedicine is an emerging tool for sleep medicine practitioners to reach and engage with patients. Unfortunately, telemedicine practitioners use of 21st century technologies are sometimes limited to medical practice laws and regulations modeled on 20th century healthcare methods. Here are some legal dos and don’ts to consider when adopting telemedicine.

drowsy driving
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Perspectives

Editor’s Message: Support for Senior Screening

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Undiagnosed obstructive sleep apnea (OSA) comes at a steep price—$3.4 billion annually, to be exact. According to the American Academy of Sleep Medicine (AASM), that’s the dollar amount of the additional medical costs of untreated moderate-to-severe OSA in middle-aged adults every year.

air traffic controller fatigue

Regulatory News

FAA Needs to Factor Air Traffic Controller Fatigue When Scheduling Varying Shifts

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Federal Aviation Administration (FAA) models for determining air traffic controller staffing needs are suitable for developing initial estimates of the number of controllers required at terminal areas and airport towers, but the models used to staff the centers that control air traffic between airports can be improved, says a new congressionally mandated report from the National Research Council.