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Comments Sought on Scheduling for 8 Drugs

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Federal Register notice: FDA seeks comments on the abuse potential, medical usefulness, trafficking, and impact of scheduling chan...

Science Board Meeting on Alternative Methods

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Federal Register notice: FDA announces a 10/7 Science Board Advisory Committee meeting that will hear an update from the new Alter...

Changes Sought in REMS Logic Guidance

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Two stakeholders call on FDA to make major changes to a draft guidance on the REMS logic model that is intended to link program de...

Prednisolone Solution Needs Stability Studies: Petition

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The drug development consulting firm Rahaa asks FDA to require stability studies under refrigerated conditions for generic version...

Peripheral/CNS Drugs Panel Renewed

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Federal Register notice: FDA renews for two years its Peripheral and Central Nervous System Drugs advisory committee.

Galderma BLA for Nemluvio Approved

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FDA approves a Galderma BLA for Nemluvio (nemolizumab), a pre-filled pen for subcutaneous injection for adults with prurigo nodula...

Objectionable Conditions in Doctors Clinical Trial

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FDA warns Lublin, Poland, physician Konrad Rejdak about Bioresearch Monitoring violations in a clinical study for which he was the...

Nowrez & Ismail Shukri CGMP Violations

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FDA warns Jordans Nowrez and Ismail Shukri Company about CGMP violations in the production of OTC drugs.

QS, MDR Violations at Globus Medical

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FDA warns Globus Medical about Quality System and Medical Device Reporting violations in its production of the Excelsius GPS surgi...

Proprietary Name Review MAPP

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A CDER Manual of Policies and Procedures lists responsibilities for the Office of Surveillance and Epidemiology and other CDER off...