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Comments Sought on Pre-Hatch-Waxman ANDAs

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Federal Register notice: FDA solicits comments on several issues related to FDAs post-approval regulation of certain drug products...

Baxter Recalls Infusion Pump Dosing Software

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Baxter Healthcare recalls its Dose IQ Safety Software used with the Spectrum IQ Infusion System due to a software defect.

Breakthrough Granted to Nasopharyngeal Carcinoma Drug

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FDA grants a breakthrough therapy designation to Shanghai Junshi Biosciences and Coherus BioSciences for toripalimab in combinatio...

FDA or Courts Should Rethink Off-Label Rules: Cato

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The Cato Institute says if FDA wont resolve its conflicting stance over off-label use and promotion, the courts should do so.

Vifor Asks FDA to Reverse Some Venofer Actions

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Vifor asks FDA to take specific steps to stay actions the agency took in a 2020 citizen petition response purporting to change the...

Researchers Get Jail Time for Falsifying Clinical Trial Data

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A Florida federal judge sentences two people to jail time and restitution for participating in a conspiracy to falsify clinical tr...

CDRH Met or Exceeded Strategic Goals: Report

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CDRH says it met or exceeded strategic goals in the period 2018-2020.

FDA Approves Keytruda Plus Lenvima for Some Cancers

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FDA approves Mercks Keytruda plus Eisais Lenvima for first-line treatment of adults with advanced renal cell cancer.

FDA Orphan Drug Designation for Allogene Cancer Drug

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FDA grants Allogenes ALLO-715 orphan drug status for treating multiple myeloma.

Jazz Pharma Hypersomnia Drug Approved

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FDA approves a Jazz Pharmaceuticals NDA for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for treating ...