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FDA Not Pursuing Suspect Chinese Heparin Firms: Lawmakers

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Republican House Energy and Commerce Committee leaders ask FDA to explain why it apparently continues to allow two Chinese compani...

Stealth Therapeutics Invisiport Cleared

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FDA clears a Stealth Therapeutics 510(k) for its Invisiport, an alternative to traditional chest ports and peripherally inserted c...

FDA Reportedly Backs Adventrx Docetaxel Trial

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FDA says a proposed single clinical study would generate sufficient data to support approval of Adventrx Pharmaceuticals docetaxel...

FDA Expanding Power Over Intrastate Commerce

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Attorneys William Koustas and John Fleder caution regulated industry to protest FDA attempts to regulate products that do not trav...

FDA Panel Backs Atricure PMA for Afib Ablation Device

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FDA's Circulatory System Devices Panel votes to recommend approval of an AtriCure PMA for its Synergy Ablation device and its use ...

FDA Clears Vapotherm Heliox Device

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FDA clears a Vapotherm 510(k) for the Precision Flow Heliox, a high-flow humidification system designed for use with blended heliu...

Final Birth Control Blood Clot Report Backs Concerns

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FDA says that results of a study it funded confirm an association between some birth control pills and increased risk of blood clo...

FDA OKs Mylan's Generic MS Contin

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FDA approves a Mylan Pharmaceuticals ANDA for a generic version of Purdue Pharma's MS Contin.

FDA OKs Lantheus Ultrasound Contrast Agent Labeling Changes

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FDA approves Lantheus Medical Imagings proposed labeling changes removing statements from the warning sections of the labeling for...

FDA Delays Dapagliflozin PDUFA Action Date

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FDA delays for three months its PDUFA action date for Bristol-Myers Squibb/AstraZenecas dapagliflozin NDA for treating Type 2 diab...