FDA Related News

Medical Devices

CDRH Medical Device Development Tools Help Developers: Shuren

CDRH director Jeffrey Shuren describes the Centers Medical Device Development Tools program and Catalog of Regulatory Science Tools.

Human Drugs

Advisory Committee Aducanumab Deliberations Explained

Three university experts say their advisory committee experience with Biogens aducanumab shows the value in randomized clinical trials that patients a...

Human Drugs

Higher Risk of Arrhythmias in Some Patients on Lamictal: FDA

FDA says studies found an increased risk of heart arrhythmias in patients with heart disease who take GlaxoSmithKlines Lamictal or a generic.

Medical Devices

FDA Acellular Dermal Matrix Caution

An FDA safety communication says there is a higher risk of complications in breast reconstruction using two specific brands of acellular dermal matrix...

Human Drugs

FDA Approves New Vyxeos Indication

FDA approves an expanded indication for Jazz Vyxeos to include pediatric patients aged one and older.

Biologics

Evive Bio BLA for Neutropenia Therapy

Evive Biotech submits a BLA for Ryzneuta, indicated for treating chemotherapy-induced neutropenia.

Medical Devices

LASIK Complaint on Violative Ads Seeks Woodcock Action

The leader of a Facebook group with 7,400 members harmed by LASIK eye correction procedures urges FDA acting commissioner Janet Woodcock to crack down...

Medical Devices

FDA Clears Lung Nodule AI Measurement Tool

FDA clears a Nines 510(k) for the NinesMeasure, a lung nodule measurement tool built with artificial intelligence that is intended to accelerate diagn...

Multiple Drug, Medical Device Violations at Tarmac Products

FDA warns Tarmac Products about multiple drug and medical device violations in its production of OTC drugs and wound dressing medical devices.

Human Drugs

Stakeholder Suggestions for Upcoming Disease Progression Workshop

Four stakeholders suggest ways FDA can improve an upcoming public workshop on disease progression models.