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FloSpine 3D-Printed Interbody Cage Cleared

[ Price : $8.95]

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

Convatecs Extracellular Matrix Wound Care Cleared

[ Price : $8.95]

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

Panel Meeting Nixed on OTC Opioid Reversal Agent

[ Price : $8.95]

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

FDA Clears Bigfoot Bio Android Diabetes App

[ Price : $8.95]

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

Noah Medicals Robotic Bronchoscopy Device Cleared

[ Price : $8.95]

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

CDER 2022 Drug Safety Priorities Report Out

[ Price : $8.95]

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

FDA, FTC Advancing Biologic Competition

[ Price : $8.95]

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

Panel to Review Lynparza sNDA for Prostate Cancer

[ Price : $8.95]

Federal Register notice: FDA announces a 4/28 Oncologic Drugs Advisory Committee meeting to review an AstraZeneca supplemental NDA...

Drug, Device Recalls Shoot Up in 2022: Report

[ Price : $8.95]

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

8 Observations in Cipla FDA-483

[ Price : $8.95]

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