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Horizon Seeks Rayos Bioequivalence Requirements

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Horizon asks FDA to require specific data and information demonstrating bioequivalence of a generic version of its Rayos.

Senate Offers Bill to Avert FDA, Government Shut Down

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The U.S. Senate offers a temporary spending measure that could avert a government shut down, including a good portion of FDAs oper...

FDA Releases FDA-483 from BRI Review Board Inspection

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FDA releases a critical five-page, seven-observation FDA-483 from a January Dallas District Office inspection at BRI institutional...

FDA Approves Medtronic Complete SE Stent

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FDA approves a new indication for Medtronics Complete SE vascular stent for use in the upper legs.

FDA Sets Device Identifier Rule

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Federal Register Final rule: FDA establishes a system to identify devices through distribution and use including a unique device i...

Guidance on Unique Device Identification Database

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Federal Register Notice: FDA releases a draft guidance: Global Unique Device Identification Database (GUDID).

Companion Diagnostics Regulatory Space Evolving Rapidly: CDRH

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CDRH Office of In Vitro Diagnostics and Radiological Health personalized medicine staff director Elizabeth Mansfield says the worl...

Stakeholders Seek Standardized REMS and Evaluations

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The American Pharmacists Association says FDA should continue moving to standardized Risk Evaluation and Mitigation Strategies pro...

FDA Orders Colored Labeling for Fentanyl Patches

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FDA orders color changes to the writing on Duragesic (fentanyl) and generic equivalent pain patches so they can be seen more easil...

Workshop on Rare Disease Product Development

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Federal Register Notice: FDA plans a public workshop 1/6-7/14: Complex Issues in Developing Drug and Biological Products for Rare ...