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Campaign to stop the spread of syphilis in Laredo

The Laredo Health Department is launching a campaign to spread awareness about sexually transmitted infections, particularly syphilis.

Erica dominguezLaredo health departmentTesting servicesLaredo educationLaredo newsHealth educatorHealth departmentSexually transmitted infectionPreproductive systemHair lossSerious conditions

New FDA Guidance Clinical Trial Considerations To Support Accelerated Approval Of Oncology Therapeutics

On April 6, 2023, AbbVie announced that it was voluntarily withdrawing ibrutinib, which was granted accelerated approval for two indications: mantle.

Marjoriee zettlerDrug administrationOncologic drugs advisory committeeRegor pharmaceuticals incDrug administration expedited developmentUs government accountability officeOncology centerDrug administration accelerated approval of malignant hematologyRegor pharmaceuticalsProject confirmReduce riskRequire stronger evidence of safety andDrug omnibus reform actConsolidated appropriations actMantle cell lymphomaMarginal zone lymphoma

New FDA Guidance Clinical Trial Considerations To Support Accelerated Approval Of Oncology Therapeutics

On April 6, 2023, AbbVie announced that it was voluntarily withdrawing ibrutinib, which was granted accelerated approval for two indications: mantle.

Marjoriee zettlerOncologic drugs advisory committeeDrug administrationUs government accountability officeDrug administration accelerated approval of malignant hematologyOncology centerDrug administration expedited developmentRegor pharmaceuticals incRegor pharmaceuticalsProject confirmReduce riskRequire stronger evidence of safety andDrug omnibus reform actConsolidated appropriations actMantle cell lymphomaMarginal zone lymphoma

FDA Issues First Untitled Letter Of The Year To HCT/P Manufacturer - Food and Drugs Law

On March 1, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published its first untitled letter of the year to Thomas Advanced Medical LLC (Thomas).

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FDA New Untitled Letter to HCT/P Manufacturer

Center for Biologics Evaluation and Research CBER at Food and Drug Administration FDA published first untitled letter of the year to Thomas Advanced Medical LLC for marketing human cells, tissues, or cellular or tissue-based products HCT/Ps without FDA premarket review.

Drug administration staffDrug administrationThomas advanced medicalPublic health serviceBiologics evaluationRegulatory considerationsHuman cellTissue based productsMinimal manipulationFederal foodCosmetic actHuman cellsHomologous useRegenerative medicine productsSame surgical procedure exceptionAnswers regarding

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