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Midterms Threaten FDA Funding: Alliance

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An analysis by the Alliance for a Stronger FDA says that the agencys fiscal year 2019 appropriations, which are part of a four-bil...

FTC Hits First iV Cocktails Seller

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The FDA charges A & O Enterprises, a seller of intravenously injected therapy products (iV Cocktails), with making a range of dece...

Vita Medical Spray-on Skin Cells Approved for Burns

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FDA approves a Vita Medical PMA for the Recell Autologous Cell Harvesting Device for treating severe thermal burns in patients 18 ...

MicuRx Gains Fast Track for Antibiotics

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FDA grants MicuRx Pharmaceuticals fast track status and a qualified infectious disease product desgination for contezolid (MRX-I) ...

Draft Guide on Clinicaltrials.com Money Penalties

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Federal Register notice: FDA makes available a draft guidance entitled Civil Money Penalties Relating to the ClinicalTrials.gov Da...

FDA Mulls New Drug Shortage Authority: Woodcock

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CDER director Janet Woodcock says the agency is considering whether it has new authorities available under FDASIA it can use to ad...

Guide on Product Identifier Requirements

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Federal Register notice: FDA makes available a final guidance entitled Product Identifier Requirements Under the Drug Supply Chain...

Guide on Heparin Labeling and Safety Testing

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Federal Register notice: FDA makes available a final guidance entitled Heparin-Containing Medical Devices and Combination Products...

Guide: Grandfathering Product Sans Product Identifier

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Federal Register notice: FDA makes available a final guidance entitled Grandfathering Policy for Packages and Homogenous Cases of ...

ADMA Biologics FDA-483 Has 8 Observations

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FDA releases an ADMA Biologics FDA-483 with eight inspection observations.