FDA Related News

Human Drugs

FDA Updates Med Guides for Gadolinium-based Contrast Agents

FDA updates a safety alert for all gadolinium-based contrast agents for MRIs to include an agency-approved new patient Medication Guides.

Human Drugs

FDA Accepts Renzapride Cardiac Safety Trial

FDA accepts the EndoLogic cardiac safety trial for renzapride in gastroparesis patients and says there was no evidence of QTc prolongation in EKG find...

Medical Devices

FDA Clears Ventripoint Diagnostics for Heart Function Analyzer

FDA clears a Ventripoint Diagnostics 510(k) for its VMS+ machine with a four-chamber heart analysis system, intended for use in the analysis of ejecti...

Federal Register

Blood Products Panel to Meet in July

Federal Register notice: FDA announces a 7/18-19 Blood Products Advisory Committee.

Medical Devices

BacterioScan UTI Detector Cleared by FDA

FDA clears a BacterioScan 510(k) for its 216Dx Urinary Tract Infection detection system.

Medical Devices

FDA Clears Caliber Imaging Microscope Enhancements

FDA clears a Caliber Imaging & Diagnostics 510(k) for modifications to its Vivascope System, a reflectance confocal microscopy device.

Biologics

FDA Approves Hospiras Epogen Biosimilar

FDA approves a Hospira BLA for Retacrit (epoetin alfa-epbx), the first biosimilar version of Amgens Epogen/Procrit (epoetin alfa) for treating anemia ...

Federal Register

Proposed Rule to Update Combo Product Regulations

Federal Register proposed rule: FDA proposes to amend its regulations concerning the classification of products as biologics, devices, drugs, or combi...

Human Drugs

Steps to Expedite Biosimilar Market Entry: Petition

The University of Illinois at Chicago College of Pharmacy suggests FDA take five steps to speed development and approval of biosimilars.

Stakeholders Question Healthcare Professional Survey

Three stakeholders raise concerns and questions about FDA-proposed research surveying healthcare professionals on aspects of prescription drug promoti...