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OMB OKs Collection of Info on Animal Drug User Fees

[ Price : $8.95]

Federal Register Notice: The Office of Management and Budget approves a collection of information on the animal drug user fee cove...

Workshop on Diabetes Management Software

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Federal Register Notice: FDA plans a public workshop 11/13: Regulatory Science Considerations for Software Used in Diabetes Manage...

Court Says Some Medtronic Claims Not Preempted

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A Maryland appeals court reverses a lower state court ruling and says that some claims against Medtronic over its Infuse device ar...

FDA Approves Vesiflos Urinary Prosthesis

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FDA approves a de novo petition to allow the marketing of Vesiflo, Inc.s inFlow Intraurethral Valve-Pump, a replaceable urinary pr...

FDA Approves Medtronic CapSureFix MRI-safe Pacemaker Lead

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FDA approves a Medtronic PMA for its CapSureFix Novus MRI SureScan 5076 Lead for use with magnetic resonance imaging.

Biosimilar Review Straining Resources: Woodcock

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CDER director Janet Woodcock says the review of biosimilar applications is straining agency resources.

FDA Guidance on Device Recalls vs. Enhancements

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FDA posts a final guidance on Distinguishing Medical Device Recalls from Medical Device Enhancements.

QS Violations Seen in Alpha Medical Inspection

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FDAs Los Angeles District Office warns Alpha Medical Instruments about Quality System violations in its manufacturing of angiograp...

Chinese Crude Heparin Firm Blocked FDA Inspection

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FDA warns Chinas Beijing Shunxin Meihua Bio-technical Co. that it must permit FDA inspection of its facility that produces crude h...

FDA to Survey on Generic Drug Appearance Changes

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FDA says it wants to survey pharmacists and patients about their experiences dealing with changes in generic drug appearance.