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FDA Clears Loma Vista Balloon Valvuloplasty Catheter

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FDA clears a Loma Vista Medical 510(k) for its True Dilatation Balloon Valvuloplasty Catheter.

Guidance on eCopy Program for Device Submissions

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Federal Register Notice: FDA releases a draft guidance, eCopy Program for Medical Device Submissions.

Oncologic Drugs Panel Meeting Canceled

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Federal Register Notice: FDA cancels an 11/8 meeting of the Oncologic Drugs Advisory Committee scheduled to discuss a Celgene NDA ...

Committee Leaders Want More Compounding Info from FDA

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House Energy and Commerce Committee members say they want a complete history of FDAs oversight on New England Compounding Center t...

Ben Venue Resumes Limited Production at Troubled Facilities

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Ben Venue Laboratories resumes production on a limited number of manufacturing lines at its troubled Bedford, OH facilities.

FDA Reviewers Question Genzyme Mipomersen Safety

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FDA medical reviewers tell the Endocrinologic and Metabolic Drugs Advisory Committee that they have safety concerns about Genzymes...

Appeals Court Expected to End Francks Lab Case

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Attorneys Kurt Karst and Jeffrey Gibbs say it is unfortunate that a federal appeals court wont get to rule on the litigation betwe...

Could HHS-FDA Politics Bring More Compounding Problems?

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Former FDA deputy commissioner Scott Gottlieb says some recent politically-directed policy changes in FDA drug regulation may make...

St. Jude May Get FDA Warning Letter

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St. Jude Medical CEO Dan Starks says he would not be surprised if an FDA inspection at the firms Sylmar, CA, manufacturing facilit...

Panel to Discuss Influenza, Hepatitis B Vaccines

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Federal Register Notice: FDAs Vaccines and Related Biological Products Advisory Committee will meet 11/14-15 to discuss a GlaxoSmi...