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Fresenius Kabi Recalls Infusion Pumps

[ Price : $8.95]

Fresenius Kabi recalls its Volumat MC Agilia Infusion Pumps and Vigilant Agilia Drug Library due to alarm and multiple software er...

Suit Seeks Info on Any Sharpless Drug Conflict

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Watchdog group Restore Public Trust files suit to get FOI documents on whether FDA acting commissioner Ned Sharpless is asserting ...

Public Meeting Seeks Priorities for New Drug Review

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FDA says it is planning an 11/7 public meeting to seek input on opportunities and priorities for CDERs Office of New Drugs.

Kala Pharma Dry Eye NDA Rejected; More Data Needed

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FDA issues Kala Pharmaceuticals a complete response letter on its NDA for KPI-121 (loteprednol etabonate) for dry eye disease sign...

FDA Tests New BE Method for Generic Topicals

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A new FDA Impact Story discusses new research undertaken to help would-be generic topical dermatological drug product developers d...

Ortho Dermatologics NDA Accepted for Acne Lotion

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FDA accepts for review an Ortho Dermatologics NDA for tazarotene 0.045% lotion for treating moderate to severe acne.

Amarin Expects Review Extension on Vascepa sNDA

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Amarin says FDA likely will extend its review of a supplemental NDA seeking an expanded indication for Vascepa (icosapent ethyl) c...

Endologix Study for Aortic Aneurysms Device

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FDA gives Endologix authorization to begin a pivotal study to evaluate the safety and effectiveness of its Nellix Chimney EndoVasc...

AveXis Inspection Observations

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FDA releases the FDA-483 with five inspection observations issued following an inspection at the AveXis control testing laboratory...

CBER FY 2018 Product Deviation Reports

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CBER releases its summary deviations report for FY 2018 covering biological products and HCT/Ps.