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2024 Device Recalls Up, Drug Recalls Down: Sedgwick

The Sedgwick full-year recall report for 2024 shows medical device recalls increasing and drug recalls decreasing.

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Medical Devices

Becton Dickinson Recalls ChloraPrep Lot

Becton Dickinson recalls one lot of ChloraPrep clear 1 mL applicators due to fungal contamination concerns.

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Human Drugs

Disappointing Data on Supernus Depression Drug

Supernus Pharmaceuticals says its Phase 2b study of SPN-820 in adults with treatment-resistant depression did not demonstrate a statistically signific...

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Human Drugs

Expanded Access to TICE BCG Substitute

FDA approves an ImmunityBIO expanded access program for recombinant BCG to help address a BCG shortage in treating bladder cancer.

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What Happens to FDA in a Budget Shutdown?

Hyman, Phelps & McNamara regulatory and medical device principal expert Richard Lewis uses his experience at FDA during the 2018-2019 government shutd...

FDA General

AdvaMed Urges HHS Reversal of FDA Staff Cuts

Advamed president Scott Whitaker writes HHS to urge a reversal of staff cuts at CDRH to avoid a negative impact on patient care.

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Human Drugs

Multiple Violations at Jagsonpal Pharmaceuticals

FDA warns Indias Jagsonpal Pharmaceuticals about CGMP deviations and other violations in its manufacturing of active pharmaceutical ingredients.

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Human Drugs

CGMP Deviations at Tyche Industries

FDA warns Indias Tyche Industries about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

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Medical Devices

Publish Guidance on Robotic Mastectomy: Petition

Harmed Americans for Reform in Medical Device Safety asks FDA to repost two safety communications and to analyze and post its findings on two studies ...

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Top Five 2024 FDA Data Quality Issues

A Med Device Online guest column lists and analyzes FDAs top five data quality citation issues in 2024.