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Braun Medical Infusion Pump Recall

[ Price : $8.95]

Braun Medical recalls its Infusomat Space Volumetric Infusion Pump System due to faulty occlusion alarms.

FDA Approves Expanded Xtandi Use

[ Price : $8.95]

FDA approves Astellas Pharmas Xtandi (enzalutamide) for an expanded use treating non-metastatic castration-sensitive prostate can...

Regulatory Review Determination on Rozlytrek Corrected

[ Price : $8.95]

Federal Register notice: FDA corrects a notice that appeared in the 7/8/2022 Federal Register that announced an agency determinati...

Panel to Tackle Pulse Oximeter Quality

[ Price : $8.95]

Federal Register notice: FDA announces a 2/2/2024 advisory committee meeting to discuss pulse oximeter quality.

Device Discontinuance and 506J List Guidances

[ Price : $8.95]

FDA issues one final and one draft guidance related to Section 506J notifications of medical device shortages.

FDA Publishes 40 Product-Specific Guidances

[ Price : $8.95]

FDA publishes 22 new and 18 revised product-specific guidances for developing generic drugs.

Device Computational Modeling Credibility Guide

[ Price : $8.95]

FDA publishes a guidance to help in assessing the credibility of computational modeling and simulation in medical device submissio...

U.S. Drug Shortages Increasing: Report

[ Price : $8.95]

An Iqvia Institute report says drug shortages continue to increase in the U.S., with the number of new shortages outpacing the num...

Provide Covid Therapeutics Distribution Info: Califf

[ Price : $8.95]

FDA commissioner Robert Califf calls on the Healthcare Distribution Alliance to give aggregate information to the agency on the di...

2 Consent Decrees Against Supplement Marketers

[ Price : $8.95]

The central Utah federal court approves two consent decrees of permanent injunction against Evig LLC and Premium Production LLC ov...