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SynCardia Systems Class 1 Recall for Heart Device

[ Price : $8.95]

SynCardia Systems begins a Class 1 recall of its Freedom Driver System because a part may fail causing the device to stop working.

FDA Grants QIDP Designation to Cempra Antibiotic

[ Price : $8.95]

FDA grants a qualified infectious disease product designation to Cempra, Inc. for its investigational antibiotic Taksta for treati...

FDA to Post Individual Consumer Comments

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Federal Register Notice: FDA plans to post comments submitted by individuals on the regulations.gov Web site.

Genentech Backs More Biosimilar Label Transparency

[ Price : $8.95]

Genentech joins AbbVie in calling on FDA to provide enhanced transparency in biosimilar labeling through a unique approach rather ...

Few Suggestions for FDA Migraine Drug Guidance

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Drug companies recommend some changes to a draft FDA guidance on developing drugs for acute migraine treatment.

FDA Grants Part of Pfizer Quillivant BE Petition

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FDA agrees with Pfizer on using partial area under the curve metrics as part of demonstrating bioequivalence to Quillivant.

2 New CDRH Learn Modules

[ Price : $8.95]

CDRH adds two modules to its CDRH Learn Web site of industry training programs.

FDA Clears Precision Spine Pedicle Screw

[ Price : $8.95]

FDA clears a Precision Spine 510(k) for the Reform Modular and HA (hydroxyapatite) Coated Pedicle Screw System.

PMA Approval for Cook Medical Endo Graft

[ Price : $8.95]

FDA approves a Cook Medical PMA for its lower-profile Zenith Alpha Thoracic Endovascular Graft, indicated for the endovascular tre...

Reprocessed Bronchoscopes Have Lower Risk: FDA

[ Price : $8.95]

FDA says the risk of infection transmission associated with reprocessed bronchoscopes appears to be lower than the risk presented ...