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FDA Clears RadiaDyne 510(k) for Radiation Dose Monitor

[ Price : $8.95]

FDA clears a RadiaDyne 510(k) for two new indications for its OARtrac radiation dose monitoring platform.

FDA Outlines Opioid Crisis Activities

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FDA commissioner Scott Gottlieb outlines the agencys efforts as part of HHS to address the nations opioid crisis.

FDA Rejects PTC Therapeutics NDA for Ataluren

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FDA sends PTC Therapeutics a complete response letter for its NDA for ataluren for treating nonsense mutation dystrophinopathies.

FDA Complete Response on Antares Testosterone Therapy

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FDA issues Antares Pharma a complete response letter on its NDA for Xyosted (testosterone enanthate) injection for testosterone re...

Ovrette Not Withdrawn Due to Safety/Effectiveness: FDA

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Federal Register notice: FDA determines that HRA Pharmas Ovrette (norgestrel) tablets, 0.075 mg, was not withdrawn from sale for r...

OriGen Biomedical Recalls Dual Lumen Catheter

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OriGen Biomedical recalls two lots of its Reinforced Dual Lumen catheter due to a separation risk involving the clear extension tu...

Class 2 for Zinc Transporter 8 Autoantibody Immunological Test

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Federal Register notice: FDA classifies zinc transporter 8 autoantibody immunological test systems into Class 2 (special controls)...

CGMP Problems Found at Indias Vital Laboratories Private

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FDA warns Indias Vital Laboratories Pvt. about CGMP violations at its API facility in Gujarat.

FDA Targets Docs for Biosimilar Education

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FDA commissioner Scott Gottlieb and CDER associate director Leah Christi describe agency efforts to educate prescribers about bios...

Multiple Violations at ELITech Netherlands Facility

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FDA warns ELITech Group about QS and MDR violations at its manufacturing facility in The Netherlands.