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Teleflex Medical Recalls Endobronchial Tube

[ Price : $8.95]

Teleflex Medical begins a Class 1 recall of its Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube because the devices connector...

Novacare Recalls Potentially Harmful Dietary Supplements

[ Price : $8.95]

Murray, UT-based Novacare recalls a number of weight loss-related dietary supplements after sample analyses by FDA revealed that t...

FDA Submits Device Reporting Info to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on medical device reporting to the Office of Management ...

Comments Extended on Quality Metrics Guidance/Meeting

[ Price : $8.95]

Federal Register Notice: FDA extends the comment period for a draft guidance on its quality metric program and the corresponding p...

Workshop on IVD Testing for Anticoagulants

[ Price : $8.95]

Federal Register Notice: FDA plans a public workshop 10/26: In Vitro Diagnostic Testing for Direct Oral Anticoagulants.

Import Alert on Cane Infusion Pumps After Inspection

[ Price : $8.95]

FDA issues an import alert to refuse entry into the U.S. infusion pumps made by Cane SpA (Rivoli-Turino, Italy).

Amgen NDA for Kidney Disease-associated Hyperparathyroidism

[ Price : $8.95]

Amgen files an NDA for etelcalcetide for treating secondary hyperparathyroidism in patients with chronic kidney disease on hemodia...

FDA Approves Dexcom Mobile Glucose Monitor

[ Price : $8.95]

FDA approves a Dexcom PMA for its Dexcom G5 Mobile Continuous Glucose Monitoring System.

FTC Takes New Type of Enforcement Action: Blog

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Attorneys Bruce Sokler and Farrah Short outline a new type of FTC enforcement action used in a consent order with Concordia and Pa...

PhRMA Faults FDA on REMS Changes Guidance

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PhRMA criticizes FDA for saying in its guidance on REMS modifications and revisions that the document is binding and did not need ...