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Info Collection on Data Monitoring Committees

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Federal Register notice: FDA sends to OMB an information collection extension entitled Establishment and Operation of Clinical Tri...

Vaccines Advisory Committee Meeting 9/30

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Federal Register notice: FDA announces a 9/30 Vaccines and Related Biological Products Advisory Committee meeting.

Class 1 Recall of Alaris Infusion Pump Bezel Assembly

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FDA classifies as Class 1 a Bio-Medical Equipment Service Co. recall of the Alaris Infusion Pump Module Model 8100 pump bezel asse...

PhRMA Updates Healthcare Professional Interaction Code

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Two Hyman, Phelps & McNamara attorneys describe updates to the PhRMA Code on Interactions with Healthcare Professionals dealing wi...

Medtronics Evolut FX TAVR System Approved

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

FDA Warns Mahita on Unapproved Covid Products

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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

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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.