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FDA Approves Gore Viabahn Endoprosthesis for In-stent Restenosis

[ Price : $8.95]

FDA approves a W. L. Gore & Associates PMA for its Viabahn Endoprosthesis for interventional treatment of in-stent restenosis in t...

FDA Submits Collection of Info on Qualitative Feedback to OMB

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Federal Register Notice: FDA submits a proposed collection of information on generic clearance for the collection of qualitative f...

Revised Guidance on Estradiol Vaginal Cream

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Federal Register Notice: FDA releases a revised draft guidance document on bioequivalence recommendations to support ANDAs for est...

Panel to Discuss InterSpinous Spacer Device

[ Price : $8.95]

Federal Register Notice: FDAs Orthopedic and Rehabilitation Devices Panel will meet 12/12 to discuss a Vertiflex PMA for the Super...

Workshop on Neonatal Therapeutics

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Federal Register Notice: FDA will hold a scientific workshop 10/28-29 to discuss applying regulatory science to neonatal therapeut...

PhRMA Complains About Double Standard with Twitter Posts

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PhRMA says it has a problem with what it calls a double standard in FDAs recent guidance on providing information on social media ...

Additional Antibiotic Development Incentives Needed: Woodcock

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CDER director Janet Woodcock tells a hearing on Capitol Hill that additional incentives are needed to spur new development of much...

FDA Draft Report on Standardizing REMS

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FDA releases a draft report entitled Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS) that describes ...

OMB OKs Collection of Info on National Stockpile

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Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on exceptions or alternativ...

FDA Proposes Iontophoresis Devices into Class 2

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Federal Register Proposed order: FDA proposes to reclassify iontophoresis devices intended for any other purposes into Class 2.