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Broadcast Ad Major Statement Q&A Guide

[ Price : $8.95]

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.

10 Observations in Aurobindo Facility Inspection

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

Covid-19 Monoclonal Antibody EUA Guidance

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FDA publishes an immediately effective guidance with its latest recommendations for submissions to support an emergency use author...

Amazon Distributing Illegal Drugs: FDA

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FDA warns Amazon that its fulfillment service is distributing unapproved and misbranded new drugs labeled as energy-enhancing supp...