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Zeta Surgical Cranial Navigation Device Cleared

[ Price : $8.95]

FDA clears a Zeta Surgical 510(k) for its Zeta Cranial Navigation System.

Busse Hospital Recalls Tracheostomy Tray Kits

[ Price : $8.95]

Busse Hospital Disposables recalls its Tracheostomy Care Tray, Dressing Change Tray, and Tracheostomy Care Set in response to Nurs...

Draft Guide on ANDA Reconsideration

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Federal Register notice: FDA makes available a draft guidance entitled Requests for Reconsideration at the Division Level Under GD...

Info Collection on E-Records/E-Signatures

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection revision entitled Electronic Records; Electronic Signatures 2...

CGMP Violations at Woorilife & Health

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FDA warns South Koreas Woorilife & Health about CGMP violations in its manufacturing of over-the-counter drugs.

MDR Violations at Neitz Instruments

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FDA warns Ichibancho, Japan-based Neitz Instruments Company about Medical Device Reporting violations in its manufacturing of its ...

Objectionable Conditions in Childrens Hospital Trials

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FDA warns Dr. Jeffrey Taub and the Childrens Hospital of Michigan about objectionable conditions in two clinical investigations.

Mixed State Court Decision in Tenofovir Case

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A California appeals court affirms in part and reverses in part a trial court decision in a case involving negligence claims again...

Revised GDUFA Request for Reconsideration Guide

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FDA publishes a draft guidance on requesting reconsideration of ANDA decisions to reflect the current GDUFA reauthorization.

CTTI Sees Barriers to Trial Reporting

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In a project conducted with FDA, the Clinical Trials Transformation Institute identifies barriers to timely and complete reporting...