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Hard times at Ardelyx as FDA rejects kidney disease drug tenapanor

pharmaphorum

The US regulator had extended its review of the drug by three months – setting back its action date from April to 29 July – but now says that deficiencies in the marketing application “preclude discussion” of labelling and post-marketing requirements. “Despite….advantageous

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Can a nasal spray tackle agitation in autism?

Pharmaceutical Technology

Dr Jeremy Veenstra-VanderWeele, professor of developmental neuropsychiatry at the Columbia University Irving Medical Center, explains that agitation is seen in the minority of autistic teens, who struggle with communication. An inability to clearly communicate with others and express their wants and needs results in frustration, he adds.

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Gabapentin side effects in men

The Checkup by Singlecare

Its also prescribed off-label for other types of nerve pain, diabetic neuropathy, mood disorders, and alcohol use disorder. That said, a 2019 study in the American Journal of Obstetrics & Gynecology showed that gabapentin might actually improve sexual function in women with vulvodynia (chronic pain in the vulva).

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Bayer sets out a proposed basis for science-based self-care products

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billion in 2019. The first principle, labelled the “Science of the Human”, asserts that self-care products should be rooted in a thorough understanding of human biology and medical insights, while the second, the “Science of Regulation”, calls for independent regulation.

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The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

The FDA Law Blog

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Medical information about a patient. Other medical information.

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Why security-first design is the fix to stalling AI pilot tools

pharmaphorum

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Cyberbullying statistics 2022

The Checkup by Singlecare

Google Survey , 2019). The Cyberbullying Research Center , 2019). The Cyberbullying Research Center , 2019). The Cyberbullying Research Center , 2019). UNICEF Poll , 2019). high school students experienced cyberbullying in 2019. In another survey in 2019, 15.7% Ditch the Label , 2017).