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Roches Endep Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Hoffmann-La Roches Endep (amitriptyline HCl) was not withdrawn from sale for safety o...

FDA Clears New Roche cobas Diagnostic Platform

[ Price : $8.95]

Roche gains FDA 510(k) clearance for the cobas pure integrated solutions, the next generation of its cobas diagnostics platform.

ClearPoint Neuro Navigation Software Cleared

[ Price : $8.95]

FDA clears a ClearPoint Neuro 510(k) for its version 2.1 of the ClearPoint Neuro Navigation software.

FDA Reminds on Endotracheal Tube Obstructions

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CDRH updates a 4/27 letter to health care providers to ensure those in operating room settings are aware of a Medtronic recall of ...

HHS Outlines FDA Projects Under Biotech Initiative

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HHS details specific FDA projects that will be undertaken as part of President Bidens recent Executive Order launching a National ...

3 Notices on Animal Minor Use/Major Species

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Federal Register notices: FDA publishes three notices about its most recent periodic reassessment of the definition of small numbe...

Pfizer Plans BLA for New Meningococcal Vaccine

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Pfizer says it will file a BLA before year end for its pentavalent meningococcal vaccine (MenABCWY).

FDA Panel to Discuss Kidney Disease Drug

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Federal Register notice: FDA announces an 11/16 advisory committee meeting to discuss an Ardelyx NDA for tenapanor hydrochloride t...

Heron Gets NDA Approved for Aponvie

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FDA approves a Heron Therapeutics NDA for Aponvie (aprepitant) injectable emulsion, indicated for preventing postoperative nausea ...

ICH Guide on Elemental Impurities

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Federal Register notice: FDA releases a final guidance entitled Q3D(R2) Guideline for Elemental Impurities.