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UK Firm Marketing Unapproved Medical Device

[ Price : $8.95]

FDA says that a UK company is marketing its blood temperature monitoring device in the U.S. without clearance or approval.

FDA Opens Clinical Investigation Technology Docket

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FDA solicits comments on using technologies and innovative methods in clinical investigations.

Multiple Violations on Noven FDA-483

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FDA releases an FDS-483 detailing 13 violations found in a Noven Pharmaceuticals inspection.

Concerns About Biologics Naming Guidance

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Stakeholders express concerns about an FDA draft guidance on biologic naming.

Most People Want FDA Ad Review

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A Kaiser Family Foundation health tracking poll finds that people think drug companies spend too much on advertising to patients a...

Comments Sought on IDE Reports/Records

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Federal Register Notice: FDA seeks comments on an information collection on investigational device exemptions reports and records.

CDER Network of Experts MAPP Out

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CDER issues a MAPP on using the Centers Network of Experts.

Novartis Agrees to Pay $390 Million to Settle Kickback Case

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Novartis says it has agreed to pay $390 million to settle U.S. Justice Department charges that it paid illegal kickbacks to specia...

FDA Clears Mauna Kea Endomicroscopy Platform

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FDA clears a Mauna Kea Technologies 510(k) for Cellvizio, a multidisciplinary confocal laser endomicroscopy platform for use in ca...

FDA Rejects Hospira BLA for Epogen Biosimilar

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FDA sends Pfizers Hospira drug unit a complete response letter for Retacrit, a biosimilar version of Amgens Epogen (epoetin alfa) ...