Food and Drug Administration (FDA)
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Curbing the opioid crisis will continue to be a key focus for the FDA. Ned Sharpless talked about new packaging rules that are expected to help stem the concerns about too many opioids on the streets.
When major depressive disorder (MDD) does not respond to at least two different types of antidepressant treatments in a moderate-to-severe depressive episode, it is reclassified as treatment-resistant depression or TRD. South San Francisco-based VistaGen Therapeutics’ AV-101 failed to meet its primary efficacy endpoints for TRD in a Phase II clinical trial.
Tablet-Based Device Manager Provides Portable and Secure Wireless Programming of Medtronic BlueSync(TM) Devices
Attain Stability(TM) Quad MRI SureScan(TM) Lead Designed for Precise Placement and Stability
The Christiana Care Health System’s Gene Editing Institute, based in Wilmington, Del., is pulling together a preliminary investigational new drug application (IND) for the U.S. Food and Drug Administration (FDA).
The CRL called for additional CMC and non-clinical information for the post-operative pain treatment. It did not specify any safety or efficacy concerns.
Nabriva Therapeutics announced that the Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for Contepo (Fosfomycin) to treat complicated urinary tract infections (cUTI), including acute pyelonephritis.
Gene Editing Institute’s study will be a novel investigation of the use of CRISPR technology to treat K-ras-positive non-small cell lung cancer
Teva Pharmaceuticals recalled 35 lots of bulk Losartan Potassium after a known carcinogen was discovered in the active pharmaceutical ingredient.
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