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Panel to Discuss Cook Zilver-PTX Drug-Eluting Stent

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Federal Register Notice: FDAs Circulatory System Devices Panel will meet 10/13 to discuss a Cook, Inc. PMA for the Zilver-PTX drug...

FDA Seeks Reps for Tobacco Products Panel

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Federal Register Notice: FDA seeks industry organizations interested in participating in selecting non-voting industry representat...

Outdated Drug Monographs a Risk to Entire System: Woodcock

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CDER director Janet Woodcock tells the OTC drug industry that outdated drug monographs on which many of them rely are a risk to th...

Info on Tobacco Substantial Equivalence OKd by OMB

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Federal Register Notice: The Office of Management and Budget approves a collection of information on exemption from substantial eq...

Public Meeting on PDUFA Reauthorization

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Federal Register Notice: FDA plans a public meeting on the reauthorization of the Prescription Drug User Fee Act for fiscal years ...

FDA 'Complete Response' on Simponi sBLA

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FDA issues Janssen Biotech a complete response letter on a supplemental BLA for Simponi (golimumab) seeking an expanded label for ...

Europeans Ratify FDA Generic Drug User Fee

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The European Fine Chemicals Group says it is backing FDAs legislative proposal for a generic drug user fee program.

FDA Clears Fluke Biomedical Patient Monitor Tester

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FDA clears a Fluke Biomedical 510(k) for the ProSim Vital Signs Simulator.

FDA OKs Mylan Generic Allergy Drug

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FDA approves a Mylan Pharmaceuticals ANDA for generic allergy drug promethazine hydrochloride tablets.

Comments Sought on Objections, Hearing Requests

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Federal Register Notice: FDA seeks comments on filing objections and requests for a hearing on a regulation or order.