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Human Drugs

FDA Clarifies Compounding Policy for GLP-1 Products

FDA clarifies its policies for compounders of GLP-1 products for weight-loss and treating diabetes following a court ruling in Texas that denied a pre...

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Medical Devices

Dexcom Hit With Warning After 2 Inspection

Dexcom says it received an FDA Warning Letter following inspections at the companys facilities in San Diego, CA and Mesa, AZ.

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FDA General

FDA Staff Given $25,000 Buyout Offers

HHS offers its 80,000 federal employees, including FDA, up to a $25,000 buyout to retire or leave their government employment as part of new move to c...

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Human Drugs

Glenmark Pharma Hit With 483 After India Inspection

FDA belatedly inspects Indias Glenmark Pharmaceuticals after a recent ProPublica investigative report found that the agency hadnt shifted any attentio...

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Human Drugs

Fresenius Kabi Recalls Ivenix Infusion Software

Fresenius Kabi recalls its Ivenix LVP software that is embedded in its Ivenix Infusion System due to reports about certain anomalies associated with t...

Marketing

Plus Therapeutics Gets Orphan Statis for Radiotherapy

FDA grants Plus Therapeutics an orphan drug designation for Rhenium (186Re) Obisbemeda, a radiotherapy for treating leptomeningeal metastases in patie...

Medical Devices

FDA Clears Zimmer Persona Knee Implant

FDA clears a Zimmer Biomet 510(k) for its Persona Revision SoluTion Femur, a revision knee implant for patients who have sensitivities to certain meta...

Federal Register

FDA Denys Hearing on Vanda Hetlioz Rejection

Federal Register notice: FDA makes available its decision to deny a request for a hearing on a CDER recent refusal to approve a Vanda supplemental NDA...

EIRS/483s

J&J Stops Phase 3 Depression Drug Program

Johnson & Johnson stops its Phase 3 VENTURA development program evaluating aticaprant as an adjunctive treatment for major depressive disorder due to ...

Animal Drugs

FDA Domestic Inspections Fall, Foreign Rise: Study

Consultants from Eliquent Life Sciences say most of FDAs drug inspection-based Warning Letters issued in fiscal year 2024 went to domestic firms, alth...