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Nizoral Not Withdrawn Due to Safety/Effectiveness: FDA

[ Price : $8.95]

Federal Register notice: FDA determines that Janssen Research & Development Nizoral (ketoconazole) tablets, 200 milligrams (mg), w...

FDA Re-approves Pfizers Withdrawn Mylotarg

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FDA approves Pfizers once-withdrawn Mylotarg (gemtuzumab ozogamicin) for treating adults with newly diagnosed acute myeloid leukem...

Guide on Medical Device Panel Meetings

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Federal Register notice: FDA announces the availability of a guidance entitled Procedures for Meetings of the Medical Devices Advi...

Draft Guide on REMS eSubmissions

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FDA releases a draft guidance on electronic submission of Risk Evaluation and Mitigation Strategies.

FDA Alert on Chinese Alcohol Wipes

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FDA warns medical professionals to not use alcohol pads or benzalkonium chloride antiseptic towelettes made by China-based Foshan ...

FDA, Others Holding Workshop on Bladder/Kidney Cancer Trials

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FDA, National Cancer Institute and the Society of Urologic Oncology announce an 11/28 public workshop to improve the conduct of ad...

FDA Clears Self-Compression Mammogram

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FDA clears a GE Healthcare 510(k) for the Senographe Pristina with Self-Compression, the first 2D digital mammography system that ...

CDER Policy on ANDA Filing Reviews

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CDER posts a new Manual of Policies and Procedures on Filing Review of Abbreviated New Drug Applications.

FDA Ending Support of Earlier Data Tabulation Model

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Federal Register notice: FDA announces the end of support for Version 1.2 of Clinical Data Interchange Standards Consortium Study ...

Device Advisory Committee Meeting Guidance Out

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FDA publishes a finalized guidance on Medical Devices Advisory Committee panel meetings.