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AGs Seek FDA Actions on Counterfeit GLP-1 Drugs

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A bipartisan coalition of 37 state Attorneys General call on FDA to take enforcement actions against online sellers of counterfeit...

2024 Device Recalls Up, Drug Recalls Down: Sedgwick

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

Becton Dickinson Recalls ChloraPrep Lot

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

Multiple Violations at Jagsonpal Pharmaceuticals

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

CGMP Deviations at Tyche Industries

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

Publish Guidance on Robotic Mastectomy: Petition

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

Top Five 2024 FDA Data Quality Issues

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

GSKs Penmenvy Vaccine for Meningococcal Disease

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FDA approves a GSK BLA for Penmenvy (meningococcal Groups A, B, C, W, and Y vaccine) for preventing invasive meningococcal disease...

Hundreds of FDA Employees Get Termination Letters

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The Trump Administration fires hundreds of FDA probationary employees over the weekend as part of its efforts to trim government f...

Deciphera Pharma Gets OK for Romvimza

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FDA approves a Deciphera Pharmaceuticals NDA for Romvimza (vimseltinib) for treating adult patients with symptomatic tenosynovial ...