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FDA Posts ICH Guide on Multi-regional Trials

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FDA posts an International Conference on Harmonization draft guidance on General Principles for Planning and Design of Multi-Regio...

Info On Postmarket Surveillance Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on postmarket surveillance to the Office of Management a...

Comments Sought on Device Recordkeeping Requirements

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Federal Register Notice: FDA seeks comments on recordkeeping requirements in Medical Devices: Current Good Manufacturing Practice ...

FDA Renews Oncologic Drugs Panel

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Federal Register Notice: FDA renews the charter of the Oncologic Drugs Advisory Committee.

Prevacid IV Not Withdrawn For S&E

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Federal Register Notice: FDA determines that Prevacid IV intravenous 30 mg/vial was not withdrawn from sale for reasons of safety ...

10 Recommendations to Transform Cancer

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The Cancer Moonshot Blue Ribbon Panel publishes a report with 10 recommendations for research that could change the course of canc...

MDSAP Participants Sought

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FDA invites medical device manufacturers to participate in a single audit program covering five countries.

FDA, Other Regulators Begin New Antimicrobial Agent Talks

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A tripartite meeting last week between FDA, European Medicines Agency and Japans Pharmaceuticals and Medical Devices Agency reach ...

Resolve Off-label Communication Dispute: House Committee

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The House Energy and Commerce Committee calls on FDA to expedite developing guidance on Constitutionally-sound off-label communica...

OCI Botox Police Hit for Low Prosecution Count

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A lengthy Reuters investigative report airs criticism about the lack of successful prosecutions in cases investigated by the FDA O...