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Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Aarti Drugs, Agila Specialties, Fenwal, Homeolab, Insight Pharmaceuticals, Medic...

Report on Observational Studies Workshop

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The Institute of Medicine publishes a report on a two-day workshop on observational studies in clinical research.

Stakeholders See Ways to Strengthen REMS Communication

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Stakeholders recommend ways to best communicate REMS information to prescribers and patients.

Violations Found at Fenwal Puerto Rico Facility

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FDAs San Juan District Office warns Fenwal about violations found in an inspection at a Puerto Rico drug and medical device manufa...

Stakeholders Want Terms in Inspection Draft Guidance Defined

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Stakeholders ask FDA to clarify how it will determine whether facility actions that delay or limit an agency inspection are unreas...

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...