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FDA Posts Animal Drug Application Actions

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Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions made during January, Februa...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Eosera and Tender Corp.

Moderna Begins Dosing in Phase 3 Covid Vaccine Trial

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Moderna says it has begun dosing participants in its Phase 3 study of its mRNA vaccine candidate for Covid-19.

Indivior Pays $600 Million in Opioid Marketing Case

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Indivior Solutions pleads guilty to one felony count and agrees to pay a total of $600 million to resolve criminal and civil liabi...

More Data Requested to Lift Hold on Solid Duchenne Drug

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FDA requests additional data and manufacturing information from Solid Biosciences to potentially lift a clinical hold on the compa...

LabCorp EUA Covers Asymptomatic, Pooled Covid Samples

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FDA reissues an emergency use authorization to LabCorp for its Covid-19 RT-PCR Test to include two new indications for use testin...

Stratus Vesta RF Cannula Cleared for Pain Relief

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FDA clears a Stratus Medical 510(k) for the Vesta RF Cannula for use in radiofrequency heat lesion procedures for relieving pain.

FDA Orders 10-year Debarment of Park

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Federal Register notice: FDA issues a 10-year debarment order against Jin Su Park for importing misbranded drugs into the U.S.

Laing Permanently Debarred by FDA

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Federal Register notice: FDA permanently debars Euton M. Laing from providing services in any capacity to a person that has an app...

Seil Debarred for 10 Years by FDA

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Federal Register notice: FDA issues a 10-year debarment order against John Seil from importing or offering for import any drug int...