FDA Related News

Federal Register

CDRH 510(k) eSubmission Template Pilot

Federal Register notice: CDRH has announced a voluntary Electronic Submission Template and Resource (eSTAR) Pilot.

Federal Register

Standardized Medicated Feed Assay Limits Guide

Federal Register notice: FDA makes available a draft guidance for industry #264 entitled Standardized Medicated Feed Assay Limits.

Comments on Combination Product Draft Guidance

PhRMA and AdvaMed suggest changes to an FDA draft guidance on feedback on combination products.

Human Drugs

Zogenix Review Extension for Dravet Syndrome Drug

FDA extends by three months its review of a Zogenix NDA for Fintepla (fenfluramine oral solution) for treating seizures associated with Dravet syndrom...

Medical Devices

Framework for Device Real-World Evidence Studies

NESTcc publishes its data quality framework and methods framework for use in real-world evidence studies.

Human Drugs

American Health Packaging Recalls Some Ranitidine for NDMA

American Health Packaging recalls 11 lots of ranitidine tablet unit dose blisters due to potential NDMA contamination.

Human Drugs

Panel Delivers Mixed Vote on Lillys Cyramza

FDAs Oncologic Drugs Advisory Committee delivers a mixed vote (six to five) to support approval of Eli Lillys supplemental BLA for Cyramza (ramuciruma...

Medical Devices

King Visions Video Laryngoscope Class 1 Recall

FDA classifies as Class 1 a King Systems recall of its King Vision Video Laryngoscope (adapter size 1/2) because they may display a reversed image.

Device Spot Shortages Reported to FDA

FDA says it has received reports of spot shortages of some medical devices due to the global coronavirus outbreak.

Medical Devices

CPAP Cleaning Safety Communication

FDA cautions against using unapproved products that claim to clean CPAP machines and accessories with ozone gas or UV light.