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TXT EUA Revoked After 510(k) Cleared on Zika Assay [65 Words] [ Price : $8.95]
Federal Register notice: FDA revokes the Emergency Use Authorization issued to Chembio Diagnostic Systems for the DPP Zika IgM Assay System because the company obtained premarket notification clearance for the device.
07/24/2020
 
 
TXT Kite Therapy Approved for Mantle Cell Lymphoma [137 Words] [ Price : $8.95]
FDA grants Kite accelerated approval for Tecartus (brexucabtagene autoleucel) for treating adult patients with relapsed or refractory mantle cell lymphoma.
07/24/2020
 
 
TXT Surgical Insufflator/Smoke Evacuator Cleared [99 Words] [ Price : $8.95]
FDA clears a Palliare 510(k) for its EVA15 insufflator and smoke evacuation system.
07/24/2020
 
 
TXT Taro Pays $205 Million in Generic Price Fixing Settlement [352 Words] [ Price : $8.95]
Taro Pharmaceuticals agrees to pay $205 million in criminal fines to resolve charges of conspiring to fix prices for generic drugs.
07/24/2020
 
 
TXT Info Collection on ICH Good Clinical Practice Guide [121 Words] [ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension for an International Council for Harmonization good clinical practice guidance.
07/23/2020
 
 
TXT Pediatric Advisory Panel to Discuss Safety Reviews [134 Words] [ Price : $8.95]
Federal Register notice: FDA announces a 9/15 Pediatric Advisory Committee meeting to discuss pediatric-focused safety reviews.
07/23/2020
 
 
TXT FDA Proposes ‘Right to Try’ Summary Rule [2638 Words] [ Price : $8.95]
FDA proposes a rule establishing deadlines and contents requirements for the annual summary to be submitted by drug sponsors and manufacturers under the Right to Try law.
07/23/2020
 
 
TXT FDA Lifts 3 Seladelpar Clinical Holds [2668 Words] [ Price : $8.95]
FDA lifts clinical holds for trials of three potential indications for CymaBay Therapeutics’ seladelpar.
07/23/2020
 
 
TXT Abbott Patient Controller Approved on iPhone [141 Words] [ Price : $8.95]
FDA approves an Abbott PMA to allow use of the company’s Patient Controller app on compatible personal Apple smartphone devices.
07/23/2020
 
 
TXT Jazz NDA for Daytime Sleepiness Approved [159 Words] [ Price : $8.95]
FDA approves a Jazz Pharmaceuticals NDA for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for treating cataplexy or excessive daytime sleepiness in patients seven years of age and older with narcolepsy.
07/23/2020
 
 
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