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Groups Give Feedback on PDUFA Proposal

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Industry and patient/consumer groups provide feedback to FDA on the negotiated Prescription Drug User Fee Act reauthorization prop...

Pixantrone NDA Resubmitted

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Cell Therapeutics resubmits its pixantrone NDA to FDA, responding to a complete response letter and recommendations from the CDER ...

FDA Debars Cioffi

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Federal Register Notice: FDA issues an order debarring Albert Cioffi MD for five years from providing services to any person with ...

Lilly Yanks Xigris Due to Low Benefit-Risk

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Eli Lilly withdraws its sepsis drug Xigris (drotrecogin alfa activated) after clinical trial results from a study called PROWESS-...

FDA Questions Medtronic Ablation System Safety

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CDRH asks the Circulatory System Devices Panel for input on the safety of Medtronics Cardiac Ablation System for which the company...

Groups Want Physician Payment Sunshine Implemented

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Seven organizations ask HHS to move quickly to implement the Physician Payments Sunshine provision of the healthcare reform law.

Guidance for Cigarette Package Warning Requirements

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Federal Register Notice: FDA releases a guidance, Required Warnings for Cigarette Packages and Advertisements Small Entity Compli...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Health Advances USA, Measurement Specialties, OraWell USA, and Rocket Medical.

FDA Orphan Status for Atox Bio Therapy

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FDA grants an orphan drug designation to Atox Bio for AB103 and its use for treating necrotizing soft tissue infections.

FDA Panel To Address AtriCure PMA Questions

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CDRH reviewers say it appears that a clinical trial intended to support approval of an AtriCure PMA for its Synergy Ablation devic...