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Medical Devices

Medline Fluid Delivery Sets Recalled

Medline Industries recalls its Medline Fluid Delivery Set with Drip Chamber because the devices were incorrectly assembled.

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Medical Devices

FDA Early Alert on Fresenius Pump Software Updates

Citing potentially lethal risk, an FDA Early Alert says Fresenius Kabi is recommending updates to some software for its Ivenix Infusion System.

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Human Drugs

FDA Warns Against Using Epinephrine Nasal Solution

An FDA alert warns healthcare professionals not to use unapproved epinephrine nasal solutions manufactured by BPI Labs and Endo USA.

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Medical Devices

QS Violations at Xoran Technologies

FDA warns Ann Arbor, MI-based Xoran Technologies about Quality System Regulation violations in its manufacturing of adulterated and misbranded compute...

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Medical Devices

8 Observations in Phillips Precision Inspection

FDA warns Elmwood, NJ-based Phillips Precision about eight Quality System violations in its contract manufacturing of orthopedic implants and instrume...

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Medical Devices

AdvaMed Trial Participation Snapshot Comments

AdvaMed recommends ways in which FDA can improve its medical device trial participation snapshot program.

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Human Drugs

Former McKinsey Exec Pleads Guilty in Opioid Case

The Justice Department says a former McKinsey executive pleaded guilty to knowingly destroying information central to the governments case against the...

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FDA General

FDA Policy Head Lands at King & Spalding

King & Spalding hires former FDA associate commissioner for policy Lauren Roth as a partner on the FDA and Life Sciences team.

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Human Drugs

Lillys Omvoh Wins Expanded Approval

FDA approves Eli Lillys Omvoh (mirikizumab-mrkz) for treating moderately to severely active Crohns disease in adults.

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Human Drugs

J&J Bladder Cancer Drug Under Review

FDA accepts for review a Johnson & Johnson NDA for TAR-200 (gemcitabine), an intravesical drug releasing system for treating certain patients with Bac...