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Increased Foreign Company Enforcement Likely: Attorneys

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Three Arnall Golden Gregory attorneys describe steps foreign drug and medical device companies can take to prepare for what they s...

Robert Foster Named FDA Chief Counsel

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HHS appoints Robert Fox Foster as FDAs next chief counsel.

Did Trump Ban Woman and Disabled at FDA?

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FDA staff tell Reuters a potentially bogus list of words that cant be used in external communications under a Trump Executive Orde...

LDT Court Ruling As Soon As Possible, Judge Says

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The Texas federal judge hearing the consolidated cases against FDA over its final rule on laboratory-developed tests promises a ru...

Bill for Canadian Drug Imports Reintroduced

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Sens. Charles Grassley and Amy Klobuchar reintroduce legislation to provide for safe importation of drugs from Canada.

FDA Clears Ezra Flash AI

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FDA clears an Ezra 510(k) for its Ezra Flash AI model for MRI imaging.

PolarityBio Gets Breakthrough Status for SkinTE

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FDA grants PolarityBio a breakthrough therapy designation for SkinTE for treating Wagner Grade 1 diabetic foot ulcers.

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.

Disappointing Data on Supernus Depression Drug

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