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FDA General

Did Trump Ban Woman and Disabled at FDA?

FDA staff tell Reuters a potentially bogus list of words that cant be used in external communications under a Trump Executive Order includes woman, di...

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Medical Devices

LDT Court Ruling As Soon As Possible, Judge Says

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

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Human Drugs

Bill for Canadian Drug Imports Reintroduced

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

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Medical Devices

FDA Clears Ezra Flash AI

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

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Medical Devices

PolarityBio Gets Breakthrough Status for SkinTE

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

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Marketing

Bipartisan Bill on Influencer, Telehealth Ads

Sens. Durbin and Marshall introduce the Protecting Patients from Deceptive Drug Ads bill to increase and improve FDA oversight of drug ads featuring s...

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Human Drugs

Report Finds Troubling Drug Imports for Weight Loss

Partnership for Safe Medicines releases a new report finding suspicious, unauthorized, and illegal ingredients for popular diabetes and obesity inject...

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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...