Steve Duffy, Digital Content Editor

Most Recent Articles by Steve Duffy, Digital Content Editor

FDA Issues Safety Communication Regarding Pen Needle Use

FDA Issues Safety Communication Regarding Pen Needle Use

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Standard pen needles have an outer cover and removable inner needle cover, while safety pen needles have an outer cover and a fixed inner needle shield that is not removed before an injection.

NDA Submitted for Novel Schizophrenia Treatment Lumateperone

NDA Submitted for Novel Schizophrenia Treatment Lumateperone

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Lumateperone, a first-in-class molecule, works via potent interactions at 5-HT2A receptors, serotonin transporters, and D1 receptors with indirect glutamatergic modulation.

FDA Outlines Plan for New Analgesic Guidance to Combat Opioid Crisis

FDA Outlines Plan for New Analgesic Guidance to Combat Opioid Crisis

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The new plan will break out the current guidance into 4 separate guidances.

Esketamine Nasal Spray NDA Submitted to FDA for Treatment-Resistant Depression

Esketamine Nasal Spray NDA Submitted to FDA for Treatment-Resistant Depression

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The NDA includes five Phase 3 studies in patients with treatment-resistant depression: 3 short-term studies, 1 withdrawal maintenance of effect study, and 1 long-term safety study.

DEA Proposal Will Significantly Cut Opioid Manufacturing in 2019

DEA Proposal Will Significantly Cut Opioid Manufacturing in 2019

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Last year, the DEA proposed a 20% reduction in the manufacturing of controlled substances for 2018 compared to 2017.

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