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7 QS Violations in Dexcom Inspection

[ Price : $8.95]

FDA warns San Diego-based Dexcom about Quality System violations in its production of unapproved glucose monitors.

API Deviations at Aspen Biopharma Labs

[ Price : $8.95]

FDA warns Indias Aspen Biopharma about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

Smiths Medical Recalls Endotracheal Tubes

[ Price : $8.95]

Smiths Medical recalls its oral/nasal endotracheal tubes after becoming aware that certain device sizes may have a smaller diamete...

Cassava Says Simufilam Failed in Alzheimers Study

[ Price : $8.95]

Cassava Sciences reports topline results from the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate Alzheimers disease, s...

Confirmatory Evidence in Non-Oncologic Rare Diseases

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FDA researchers examine the use of confirmatory evidence with one adequate and well-controlled trial in non-oncologic drug rare di...

FDA Adds New Chief Operating Officer

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FDA selects former consultant Barclay Butler as its deputy commissioner for operations and chief operating officer.

Regulate Silver Fluoride as Drug: Petition

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Advantage Silver Dental Arrest asks FDA to rescind medical device approvals for silver diamine fluoride and silver fluoride agents...

Solriamfetol Phase 3 Trial Meets Endpoints

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Axsome says its solriamfetol met the primary and secondary endpoints in the Phase 3 FOCUS trial in attention deficit hyperactivity...

Vaccine Studies Should Have Transmission Rate Data: Marks

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CBER director Peter Marks says vaccine clinical trial designs should evaluate the investigational vaccines effect on disease trans...

Breakthrough Status for AI Electrocardiogram

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FDA grants Powerful Medical a breakthrough device designation for its PMcardio STEMI artificial intelligence electrocardiogram mod...