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Medtronics Evolut FX TAVR System Approved

[ Price : $8.95]

FDA approves a Medtronic PMA for its Evolut FX TAVR system for treating severe aortic stenosis patients.

FDA Warns Mahita on Unapproved Covid Products

[ Price : $8.95]

FDA sends a Warning Letter to Mahita, LLC (Suwanee, GA) after determining that the firm was marketing unapproved and misbranded pr...

Siemens De Novo Granted for Liver Fibrosis Test

[ Price : $8.95]

FDA grants a de novo authorization to Siemens Healthineers for its Enhanced Liver Fibrosis Test and its use with the Advia Centaur...

FDA Aurobindo Pharma Inspection Has 7 Observations

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FDA releases an FDA-483 with seven observations from an inspection at Indias Aurobindo Pharma Unit 1.

FDA Approves Expanded Xarelto Indication

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FDA approves an expanded indication for Janssens Xarelto to include patients with recent lower extremity revascularization under s...

7 Observations in Jubilant Generics FDA-483

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FDA released the FDA-483 with seven observations from an inspection at Indias Jubilant Generics drug manufacturing firm.

FDAers Boost Viral Clearance in Continuous Manufacturing

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FDA says CDER researchers have developed a three-step process to promote viral clearance during continuous manufacturing of therap...

Senators Want Info on FDA Relationship with McKinsey in Opioid Crisis

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A bipartisan group of six senators quizzes FDA on the potential conflicts of interest in agency contracts with McKinsey since the ...

CGMP Violation Found in Toyobo Inspection

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FDA warns Japans Toyobo Co. about a CGMP violation in its manufacturing of finished drugs.

Product-specific Guidances for ANDAs

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Federal Register notice: FDA updates its listing of product-specific draft and revised draft guidances that provide recommendation...