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Hospira Recalls 1 Bleomycin Lot

[ Price : $8.95]

FDA says Hospira has recalled one lot of bleomycin for injection following a confirmed report of glass particulate in one vial.

QS Issues at Fresenius Medical Care

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FDA warns Fresenius Medical Care Holdings about Quality System regulations violations in its work as a specification developer for...

East Fork Cultivars Illegal CBD Products

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FDA warns Takilma, OR-based East Fork Cultivars about marketing misbranded unapproved new drugs containing cannabidiol.

Broadcast Ad Major Statement Q&A Guide

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FDA publishes a question-and-answer guidance on requirements for the major statement in direct-to-consumer broadcast ads.

Dextrum Laboratories CGMP Violations

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FDA warns Miami, FL-based Dextrum Laboratories about CGMP violations in its production of finished drugs.

FDA OKs Updated Carvykti Boxed Warning

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FDA approves an updated Boxed Warning for Janssen/Legend Biotechs Carvykti to state that secondary cancers have occurred in about ...

Reformulating Drugs Containing Carbomers

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FDA publishes an immediately effective guidance intended to expedite the reformulation of drug products containing carbomers manuf...

Hospira Sodium Bicarbonate Recall

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FDA says Hospira recalled one lot of each of three injection products due to the possible presence of glass particulate matter.

Botanical Be Selling Unapproved Drugs: FDA

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FDA warns El Paso, TX-based Botanical Be about marketing products labeled as dietary supplements that legally are misbranded, unap...

FDA Approves AvertD Opioid Use Test

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FDA approves AutoGenomics AvertD test that uses DNA to assess individuals risk of developing opioid use disorder.