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ACLA Views on PCCP Draft Guidance

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The American Clinical Laboratory Association submits comments to an FDA draft guidance on medical device predetermined change cont...

RFK Jr. Says Some FDA Departments Have to Go

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In an interview the day after the election, president-elect Donald Trumps top health advisor Robert F. Kennedy Jr. says there are ...

Breakthrough Designation for SeaStar Dialysis Device

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FDA grants a fourth breakthrough device designation for SeaStar Medicals Selective Cytopheretic Device.

9 Observations in Staska Pharmaceuticals FDA-483

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FDA releases the form FDA-483 with nine observations from an inspection at the Staska Pharmaceuticals outsourcing facility in Benn...

Clozapine REMS Curbs Treatment: Comments

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Three mental health stakeholders call on two FDA advisory committees to recommend changes to the clozapine REMS.

Zeta Gets Navigation System Improvements Cleared

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FDA clears a Zeta Surgical 510(k) for its Zeta Navigation System for use with expanded instruments and enhanced hospital connectiv...

Advisors Asked for ProSense Benefits, Risks

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FDA raises questions to be considered by members of its General and Plastic Surgery Advisory Committee about IceCare Medicals ProS...

Extended Review for Organons Vtama sNDA

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FDA extends by three months its review of an Organon supplemental NDA for Vtama (tapinarof) cream and its use for treating atopic ...

Objectionable Conditions at Hospital IRB

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FDA warns the Kittanning, PA-based Armstrong County Memorial Hospital IRB about objectionable conditions identified in a Bioresear...

FDA Cant Regulate AI on its Own: Califf

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FDA commissioner Robert Califf says collaboration with external stakeholders is needed to adequately monitor and regulate artifici...