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Fagron Recalls Lets Gel Convenience Packs

[ Price : $8.95]

Fagron recalls its Lets Gel Kit Convenience Packs due to potential microbial contamination of non-sterile products.

Philips Recalls Forte Gamma Camera System

[ Price : $8.95]

Philips Medical Systems recalls (Class 1) the Forte Gamma Camera System due to a nonconforming material/component.

RedHill Bio Gains H. Pylori Approval

[ Price : $8.95]

FDA approves a RedHill Biopharma NDA for Talicia (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules for tr...

DiFusion Spinal Interbody Device Cleared

[ Price : $8.95]

FDA clears a DiFusion 510(k) for the Xiphos-ZF Spinal interbody device.

Latest Federal Register Notices

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FDA Review posts the Federal Register notice for the week ending 8/1/2019.

Hep D Virus Drug Development Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Chronic Hepatitis D Virus Infection: Developing Drugs for T...

Draft Guide on Generic Drug User Fees

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Federal Register notice: FDA makes available a draft guidance entitled Assessing User Fees under the Generic Drug User Fee Amendme...

Trump Taps MD Andersons Hahn as FDA Head

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President Donald Trump chooses to nominate MD Anderson chief medical officer Stephen Hahn to be FDA commissioner.

Panel to Review Correvio Atrial Fibrillation Drug

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Federal Register notice: FDA has announced a 12/10 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss a Correvio...

Novartis Trial Misses Superiority in Cosentyx Trial

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Novartis says its EXCEED head-to-head trial comparing Cosentyx (secukinumab) to AbbVies Humira (adalimumab) in patients with activ...