FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Human Drugs

FDA OKs Lillys Retevmo for Some Thyroid Cancers

FDA gives traditional approval to Lillys Retevmo for some thyroid cancers in patients aged two and up.

latest-news-card-1
FDA General

Appropriators Slash FDA Budget by $450 Million

A House Appropriations subcommittee slashes $450 million (6%) from FDAs fiscal year 2025 budget.

Medical Devices

FDA Clears Avicenna.AIs Vertebral Fracture Detector

FDA clears an Avicenna.AI 510(k) for its CINA-VCF, a triage and notification artificial intelligence tool for detecting unsuspected vertebral compress...

latest-news-card-1
Medical Devices

Getinge Clinical Decision Support Software Cleared

FDA clears a Getinge 510(k) for its innovative clinical decision support software Talis +ACG (Advanced Clinical Guidance).

latest-news-card-1
Medical Devices

Spinal Simplicity Anterior Cervical Plate Cleared

FDA clears a Spinal Simplicity 510(k) for its Wolffs Law Anterior Cervical Plate System.

latest-news-card-1
Human Drugs

CGMP Violations at Malaysias TCT Neutraceuticals

FDA warns Malaysias TCT Neutraceuticals about CGMP violations in its manufacturing of OTC drugs.

latest-news-card-1
Federal Register

CDER AI Pharmacovigilance Meeting Program

Federal Register notice: CDER announces the Emerging Drug Safety Technology Meeting program for stakeholders to discuss the use of artificial intellig...

latest-news-card-1
Medical Devices

Insulet Recalls Omnipod DASH Insulin Manager

Insulet recalls (Class 1) its Omnipod DASH Insulin Management Systems Personal Diabetes Manager after receiving reports battery issues.

latest-news-card-1
Human Drugs

Cosmetic Solutions CGMP, Unapproved Drug Violations

FDA warns Boca Raton, FL-based Cosmetic Solutions about CGMP and unapproved new drug violations in its manufacturing of finished drugs.

latest-news-card-1
Human Drugs

Drug QA Inspections Up 40%: Report

The Office of Pharmaceutical Quality FY 2023 annual report says drug quality assurance inspections were up 40% over FY 2022 and mutual recognition agr...