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FDA Approves Medtronic CapSureFix MRI-safe Pacemaker Lead

[ Price : $8.95]

FDA approves a Medtronic PMA for its CapSureFix Novus MRI SureScan 5076 Lead for use with magnetic resonance imaging.

Biosimilar Review Straining Resources: Woodcock

[ Price : $8.95]

CDER director Janet Woodcock says the review of biosimilar applications is straining agency resources.

FDA Guidance on Device Recalls vs. Enhancements

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FDA posts a final guidance on Distinguishing Medical Device Recalls from Medical Device Enhancements.

QS Violations Seen in Alpha Medical Inspection

[ Price : $8.95]

FDAs Los Angeles District Office warns Alpha Medical Instruments about Quality System violations in its manufacturing of angiograp...

Chinese Crude Heparin Firm Blocked FDA Inspection

[ Price : $8.95]

FDA warns Chinas Beijing Shunxin Meihua Bio-technical Co. that it must permit FDA inspection of its facility that produces crude h...

FDA to Survey on Generic Drug Appearance Changes

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FDA says it wants to survey pharmacists and patients about their experiences dealing with changes in generic drug appearance.

FDA Clears Clinical Innovations Uterine Contraction Monitor

[ Price : $8.95]

FDA clears a Clinical Innovations (Salt Lake City) 510(k) for its Koala Toco, a tocodynamometer that is designed to utilize air-ch...

FDA Not Supporting Boxed Warning Removal for Chantix

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FDA says it wants data from an upcoming trial before it can consider removing a boxed warning on Pfizers smoking cessation drug Ch...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Alpha Medical Instruments, Beacon Hill Medical Pharmacy, Beijing Shunxin Meihua ...

FDA Sends Collection of Info on Exports to OMB

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Federal Register Notice: FDA submits a proposed collection of information on notification and recordkeeping requirements for expor...