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Panel to Review Pulse Oximeter Accuracy

[ Price : $8.95]

Federal Register Notice: FDA announces an 11/1 Advisory Committee meeting to discuss ongoing concerns that pulse oximeters may be ...

FDA Challenges Illicit Trade Workshop Attendees

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FDA associate commissioner Mark Abdoo calls for greater collaborative efforts worldwide to combat illicit trade in healthcare prod...

Baxter Clearlink Solution Set Recall is Class 1

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FDA says Baxter Healthcares recall of its Clearlink Basic Solution Sets with Duovent is Class 1.

Regulatory Review Period for Caplyta

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Intra-Cellular Therapies Ca...

Advisors to Discuss Pulse Oximeter Accuracy

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FDA says the Anesthesiology and Respiratory Therapy Devices Panel will meet virtually on 11/1 to discuss issues of potential pulse...

Elemental Impurities Guidance

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FDA publishes an International Conference on Harmonization revised guidance on elemental impurities in drug products.

Tavalisses Regulatory Review Period Determined

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Rigel Pharmaceuticals Taval...

FDA Investigators Target Pharmaceutical Water Systems

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CDER Office of Manufacturing Quality director Francis Godwin warns that FDA investigators are paying close attention to pharmaceut...

FDA Approves Mallinckrodt Kidney Drug

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FDA approves Mallinckrodts Terlivaz (terlipressin) injection for improving kidney function in certain adults with hepatorenal synd...

Bacitracin Withdrawn Due to Safety: FDA

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Federal Register notice: FDA determines that intramuscular antibiotic bacitracin for injection, 10,000 units/vial and 50,000 units...