FDA Related News

FDA General

Lilly Gets Expanded Indication for Verzenio

FDA approves an expanded indication for Eli Lillys Verzenio (abemaciclib), in combination with endocrine therapy for the adjuvant treatment of adult p...

Medical Devices

FloSpine 3D-Printed Interbody Cage Cleared

FDA clears a FloSpine 510(k) for its a 3D-printed titanium Ti-Largo cervical interbody cage system to support the spine after a cervical collapse or a...

Medical Devices

Convatecs Extracellular Matrix Wound Care Cleared

FDA cleared a Convatec 510(k) for its InnovaMatrix PD particulate placental extracellular matrix medical device for wound management.

Human Drugs

Panel Meeting Nixed on OTC Opioid Reversal Agent

Federal Register notice: FDA cancels for undisclosed reasons a 3/20 joint meeting of the Nonprescription Drugs Advisory Committee and Anesthetic and A...

Human Drugs

FDA Clears Bigfoot Bio Android Diabetes App

FDA clears a Bigfoot Biomedical 510(k) for the Android version of the Bigfoot Unity Mobile App, which is a part of the Bigfoot Unity Diabetes Manageme...

Medical Devices

Noah Medicals Robotic Bronchoscopy Device Cleared

FDA clears a Noah Medical 510(k) for the Galaxy System, a robotic-navigated bronchoscopy device and accessories that are intended to provide bronchosc...

Human Drugs

CDER 2022 Drug Safety Priorities Report Out

FDA publishes the CDER Drug Safety 2002 Priorities Report reviewing the many drug safety activities the Center undertook in 2022.

Human Drugs

FDA, FTC Advancing Biologic Competition

CDER director Patrizia Cavazzoni describes how FDA and FTC are working collaboratively to increase competition for biologic products.

Drug, Device Recalls Shoot Up in 2022: Report

The Sedgwick 2022 recall report says both drug and medical device recall events surged higher in 2022, with drugs outpacing devices.

Human Drugs

8 Observations in Cipla FDA-483

FDA releases the form FDA-483 with eight observations from an inspection at the Madhya, Pradesh, India-based Cipla facility that manufactures sterile ...