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Medtronic Recalls Cerebrospinal Fluid Drain Device

[ Price : $8.95]

Medtronic Neurosurgery recalls certain Becker and Exacta External Drainage and Monitoring Systems due to a risk for cracks and lea...

2 Guides on Cell/Tissue Disease Transmission Delayed

[ Price : $8.95]

Federal Register notice: FDA delays by three months the effective dates of two final guidances on reducing the risk of transmissio...

Olympus Recalls Endoscope Accessory

[ Price : $8.95]

Olympus recalls its MAJ-891 endoscope accessory due to infection risks that may result from improper device reprocessing.

Lawyers Critique Guide on Unapproved Use Dissemination

[ Price : $8.95]

A Duane Morris client alert analyzes a recent FDA guidance on communicating scientific information to healthcare professionals abo...

Pfizer Seeks Braftovi Full Approval in Colon Cancer

[ Price : $8.95]

Pfizer seeks full approval for current accelerated-approved Braftovi (encorafenib) in combination with cetuximab (Erbitux) and mFO...

FDA Clears Hearing Aid/Smart Glasses

[ Price : $8.95]

FDA clears an EssilorLuxottica 510(k) for its over-the-counter Nuance Audio Glasses that provide an open-ear hearing solution inte...

Vertex Non-Opioid New Pain Drug Approved

[ Price : $8.95]

FDA approves a Vertex Pharmaceuticals NDA for Journavx (suzetrigine), a first-in-class non-opioid pain drug for treating moderate ...

Info Collection on Rx Labeling Requirements

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection revision entitled Labeling Requirements for Prescription Drugs...

Biosimilar User Fees Info Collection Revised

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection revision entitled Biosimilars User Fee Program.

FDA Alert on Fresenius Kabi Infusion Pumps

[ Price : $8.95]

An FDA alert advises healthcare providers about Fresenius Kabis Ivenix large-volume pumps and their increased chance of issuing a ...