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Samsungs NeuroLogica 510(k) Cleared for X-ray System

[ Price : $8.95]

Samsung Electronics subsidiary NeuroLogica gains 510(k) clearance for its Samsung GC85A Digital Radiography (DR) system, a ceiling...

GW Pharma Gets Fast Track for Cannabidiol Therapy

[ Price : $8.95]

FDA grants GW Pharmaceuticals a fast track designation for a proprietary intravenous form of cannabidiol to treat neonatal hypoxic...

Medtronic Recalls EnVeo R Loading System

[ Price : $8.95]

FDA says that Medtronic is recalling its EnVeo R loading system due to the presence of particulate.

Stryker 510(k) Cleared for Mako Robotic Knee Surgery

[ Price : $8.95]

FDA clears a Stryker Orthopedics 510(k) to allow its Mako robotic surgery device to be used in total knee reconstructive applicati...

FDA Fast Track for Theravance Biopharma Nutritional Therapy

[ Price : $8.95]

FDA grants fast track status for Theravance Biopharmas TD-8954 for short-term use with enteral feeding to achieve early nutritiona...

Tissue Marker into Class 2

[ Price : $8.95]

Federal Register Final order: FDA classifies the internal tissue marker into Class 2.

Risk Disclosure Guidance for Ads

[ Price : $8.95]

FDA issues a revised draft guidance updating its recommendations for disclosing risk information in consumer prescription drug ads...

Insulin Up the Nose Helps Alzheimers?

[ Price : $8.95]

Researchers report that insulin delivered high up in the nasal cavity goes to affected areas of the brain with lasting results in ...

Guidance on OTC Pediatric Acetaminophen Liquid Drugs

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen.

Insys Proposed Changes for Product-specific BE Guidance

[ Price : $8.95]

Insys Therapeutics asks FDA to add four conditions to its draft product-specific BE guidance on fentanyl sublingual spray.