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FDA releases a draft guidance on electronic submission of Risk Evaluation and Mitigation Strategies.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

CDRH EFS Program is Working: Study

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CDRH officials say the Centers early feasibility study program is benefitting sponsors, FDA, and the public.

FDA Steps Up Monitoring of PD-1/PD-L1 Inhibitors: Woodcock

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CDER director Janet Woodcock says the agency is more closely monitoring the safety of PD-1/PD-L1 inhibitors after an investigation...

Charleston Reacquires Hydrocodone Pipeline Rights

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Charleston Laboratories says it will resubmit the NDA for its CL-108 pain management drug after ending a collaboration with Daiich...