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FDA Clears Pryor Medical ER-REBOA Catheter

[ Price : $8.95]

FDA clears a Pryor Medical Devices 510(k) for the ER-REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta) catheter fo...

FDA Panel Backs AstraZeneca Gout Drug

[ Price : $8.95]

FDAs Arthritis Advisory Committee votes 10 to 4 to recommend approval of AstraZenecas lesinurad oral tablets for treating hyperuri...

CDRH Sees More IDE 1st Cycle Approvals with Pre-submissions

[ Price : $8.95]

CDRH says a recent analysis of IDE pre-submissions showed that IDEs submitted after a pre-submission have a greater likelihood of ...

Medical Policy Acting Director Jarow Moves to Center Office

[ Price : $8.95]

CDER Office of Medical Policy (OMP) acting director Jonathan Jarow leaves his post to join the Office of the Center Director due t...

FDA Issues Interim Policy on Drug Compounding

[ Price : $8.95]

A new FDA interim policy on drug compounding indicates that the agency does not intend to take an enforcement action under certain...

Guidance on Tobacco Product Environmental Assessments

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Federal Register Notice: FDA releases a guidance: National Environmental Policy Act; Environmental Assessments for Tobacco Product...

FDA Stalevo Safety Review Finds No Increased CV Risk

[ Price : $8.95]

FDA says a recently concluded drug safety review of a Novartis Parkinson's therapy, Stalevo, has found no clear evidence of an inc...

New CDER Policy on BLA Team Reviews

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A new CDER policy document outlines the procedures in the Office of Biotechnology Products and the Office of Manufacturing Quality...

House Subcommittee Hearing on Diagnostic Tests

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The House Energy and Commerce Committee health subcommittee schedules a 10/29 hearing on Examining the Regulation of Diagnostic Te...

OMB OKs Info on Device Recall

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Federal Register Notice: The Office of Management and Budget approves a collection of information on medical device recall authori...