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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) ...

Guidance on Animal Rule for Drug/Biological Development

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Federal Register Notice: FDA releases a guidance: Product Development Under the Animal Rule to support approval of a drug or biolo...

Guidance on Reformulated Drugs with Alternate Administration Routes

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Federal Register Notice: FDA releases a guidance entitled: Nonclinical Safety Evaluation of Reformulated Drug Products and Product...

FDA Warning Letter Cites 2 Sandoz Indian Sites

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FDA sends Sandoz a Warning Letter citing Indian manufacturing sites in Kalwe and Turbhe over GMP concerns.

FDA Approves Amgens Melanoma Therapy

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FDA approves an Amgen BLA for Imlygic (talimogene laherparepvec), a genetically modified oncolytic viral therapy indicated for the...

UK Firm Marketing Unapproved Medical Device

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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.