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Proprietary Name Review Paper Released

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Federal Register Notice: FDA releases a concept paper on the PDUFA pilot project on proprietary name review.

Spiriva Users Can Breathe a Little Easier on New Safety Data

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FDA says preliminary results from a recent study show no increased stroke risks with Boehringer Ingelheims Spiriva HandiHaler comp...

Lilly Settles State Zyprexa Suits

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Lilly agrees to pay $62 million to 32 states to resolve Zyprexa marketing and promotion lawsuits.

FDA Finalizes Pilot Program on Proprietary Names

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FDA makes minor tweaks to its planned pilot program that is intended to shift the primary burden for providing data that justify p...

Renewal Research Supplements Marketed as Drugs: FDA

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FDAs San Francisco District Office says a Renewal Research Web site makes claims for products that establish them as unapproved ne...

Thrombate III Promo Makes Misleading Claims: FDA

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CBER says a Thrombate III sell sheet makes misleading safety and superiority claims.

Guidance on Contrast Imaging Considerations

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FDA issues a guidance to help medical imaging drug and device developers with products providing image contrast enhancement.

FDA Approves HDE on Pump for Hearts Right Side

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FDA approves a Humanitarian Device Exemption for Levitronix CentriMag Right Ventricular Assist System, the first heart pump that p...

Bayer Warned Over Yaz TV Spots

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DDMAC says two Bayer TV ads for its Yaz contraceptive broaden the indication, overstate efficacy, and minimize risk.

FDA Backs Infant Cold Drug Label Change

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CDER director Janet Woodcock says FDA supports voluntary labeling changes being made to pediatric cough and cold medicines to warn...