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Medical Devices

QS Issues at Fresenius Medical Care

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

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Human Drugs

East Fork Cultivars Illegal CBD Products

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

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Marketing

Broadcast Ad Major Statement Q&A Guide

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

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Human Drugs

Dextrum Laboratories CGMP Violations

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

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Human Drugs

FDA OKs Updated Carvykti Boxed Warning

FDA approves an updated Boxed Warning for Janssen/Legend Biotechs Carvykti to state that secondary cancers have occurred in about 10% of patients rece...

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Human Drugs

Reformulating Drugs Containing Carbomers

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

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Human Drugs

Hospira Sodium Bicarbonate Recall

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

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Human Drugs

Botanical Be Selling Unapproved Drugs: FDA

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

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Medical Devices

FDA Approves AvertD Opioid Use Test

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

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Human Drugs

10 Observations in Aurobindo Facility Inspection

Aurobindo Pharma says FDA had 10 procedural observations from a pre-approval inspection at the firms new injectable facility in East Windsor, NJ.