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ANDA Reference Products Guidance

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Federal Register Notice: FDA makes available a final guidance on how to reference Approved drug products in ANDA submissions.

Artificial Intelligence Committee Meeting Notes

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FDA releases a meeting summary with recommendations on artificial intelligence and machine learning from the Patient Engagement Ad...

MAPP on REMS Development

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CDER publishes a MAPP on responsibilities and procedures for developing two types of REMS.

Guide on Monitoring Devices Enforcement Policy

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FDA posts a revised guidance on its enforcement policy for Remote Monitoring Devices Used During Covid-19 Emergency.

Guide on Tobacco Product Perception/Intention Studies

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Federal Register notice: FDA makes available a draft guidance conducting tobacco product perception and intention studies.

Device Panel Votes Down Neovascs Reducer

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FDAs Circulatory System Devices Advisory Panel votes 13 to 3 against recommending PMA approval for Neovascs Reducer for treating c...

CGMP Violations at KVK-Tech

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FDA warns KVK-Tech about CGMP violations in its production of finished drugs.

Meeting on Drug Supply Chain Security Act

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Federal Register notice: FDA announces a 12/8-9 virtual public meeting entitled The Drug Supply Chain Security Act Pilot Project P...

Panel Reviews Spironolactone for Certain Heart Failure Patients

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Federal Register notice: FDA announces a 12/16 advisory committee meeting to discuss spironolactone for the proposed treatment of ...

Panel to Discuss Novartis sNDA for Entresto

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Federal Register notice: FDA announces a 12/15 advisory committee meeting that will review a Novartis supplemental NDA for Entrest...