Posts Tagged fda

FDA Law Blog: FDA Releases Draft Guidance on Wholesale Drug …

Thursday, December 11th, 2014 | Permalink

Get Updates via E-mail. Enter your email address to automatically receive new posts to the FDA Law Blog via e-mail. Delivered by FeedBurner · Subscribe in a reader …. The Draft Guidance states that FDA prefers that reports be submitted with extensible markup language (“ XML ”) files in Structured Product Labeling (“SPL”) format . Information can be submitted by a link to a web portal on FDA's website. All in all, FDA's Draft Guidance seems to provide some clarity for …

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FDA Law Blog: FDA Releases Draft Guidance on Wholesale Drug …

St. Jude To Acquire CardioMEMS As FDA Approves Heart Failure Monitor

Monday, June 2nd, 2014 | Permalink

FDA approved the CardioMEMS HF wireless heart-failure monitor, and St. Jude has exercised its option to buy the technology and its manufacturer. The approval is based on the results of the CHAMPION pivotal trial, which showed that patients monitored with the remote, implantable system needed fewer hospitalizations.

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St. Jude To Acquire CardioMEMS As FDA Approves Heart Failure Monitor

FDA Catches Heat For Plans To Raise Standards For Hospital Glucose Meters

Monday, May 12th, 2014 | Permalink

An FDA draft guidance issued earlier this year on hospital glucose meters has attracted an unusual amount of attention, including criticism from clinicians, companies and others who worry it could cut off access to point-of-care glucose testing in patient cases where it is needed. The agency says it is taking appropriate measures to address a safety issue, and that some of the criticism is misdirected.

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FDA Catches Heat For Plans To Raise Standards For Hospital Glucose Meters

What Makes A Device Class III? FDA Proposes New Language To Clarify

Monday, March 31st, 2014 | Permalink

FDA issued a proposed rule that introduces five newly defined categories that describe situations for devices when a class III designation, requiring a PMA and other heightened standards, will always be necessary.

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What Makes A Device Class III? FDA Proposes New Language To Clarify

Benvenue Medical Touts Next-Generation Treatment For Vertebral Compression Fractures

Wednesday, March 26th, 2014 | Permalink

At the recent CIRCE meeting, researchers presented positive clinical data comparing Benvenue Medical Inc.’s Kiva vertebral compression fracture system versus Medtronic’s market-leading Kyphon kyphoplasty system, providing a boost for Benvenue, which is awaiting FDA 510(k) clearance of its device.

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Benvenue Medical Touts Next-Generation Treatment For Vertebral Compression Fractures