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Workshop on Neonatal Therapeutics

[ Price : $8.95]

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.

CDER Denies Petition Seeking Reformulated ADHD Drugs

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CDER denies a 2006 citizen petition from physician John C. Kulli that requested it issue a regulation requiring attention deficit ...

FDA Approves New Test for Detecting Yeast Pathogens

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FDA approves a de novo petition to allow the marketing of T2 Biosystems direct blood test for detecting five yeast pathogens that ...

FDA Breakthrough Designation for Eylea in Diabetic Retinopathy

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FDA grants Regeneron Pharmaceuticals a breakthrough therapy designation for Eylea injection for treating diabetic retinopathy in p...

OPDP Cites Cipher Pharma Over e-Pharm Emails

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CDERs Office of Prescription Drug Promotion objects to a Cipher Pharmaceuticals e-Pharm/alert email for Lipofen (fenofibrate capsu...