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Medical Devices

Baxter Recalls Novum IQ Infusion Pump

Baxter Healthcare recalls its Novum IQ Syringe Infusion Pump because the device may indicate an infusion is complete when it is not.

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Human Drugs

Smart Womens Choice Consent Decree

FDA says the Arizona federal court has approved a permanent injunction against Smart Womens Choice and its CEO to prevent them from illegally distribu...

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Medical Devices

QS Violations at Ming Fai Industrial

FDA warns Chinas Ming Fai Industrial Co about QS violations in its production of ultrasound gel and probe cover products.

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Human Drugs

Insanitary Conditions at Indias Global Pharma

A lengthy FDA Warning Letter details issues at Indias Global Pharma Healthcare that led to contaminated ophthalmic drugs.

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Human Drugs

Bayer Withdrawing Aliqopa After Failed Study

Bayer withdraws its NDA for Aliqopa (copanlisib) for adult patients with relapsed follicular lymphoma who have received at least two prior systemic th...

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Federal Register

Nonprescription Panel Renewed for 2 Years

Federal Register notice: FDA renews the Nonprescription Drugs Advisory Committee for an additional two years.

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Medical Devices

Former BD Exec Petitions FDA on Mesh Products

Former Becton Dickinson medical director Hooman Noorchashm petitions FDA to warn patients about the unknown and inadequately studied effect of FDA-reg...

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Human Drugs

ODAC Looking at Long Delays in 2 Acrotech Trials

FDA asks the Oncologic Drugs Advisory Committee whether Acrotech Biopharmas plan to complete a confirmatory trial for two cancer drugs years after the...

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Medical Devices

Cardinal Health Recalls Infusion Pump Syringes

Cardinal Health recalls its latest version (6/2023) of its Monoject syringes branded as Cardinal Health Monoject syringes because their dimensions dif...

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Biologics

Comments on Cell & Gene Comparability Guide

Four stakeholders comment on an FDA draft guidance on comparability of human cell and gene therapy products and suggest improvements.