Monthly ArchiveMarch 2019

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present

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The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA. …

Written Requests Issued

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Updated list of approved active moieties to which FDA has issued a Written Request for pediatric studies …

The Midwest Battles Historic Floods In The Aftermath Of ‘Bomb Cyclone’

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A powerful weather system swept through the region last week, bringing blizzard conditions and leaving many communities with record-setting floods. …

Bay Area’s High Cost Of Living Squeezes Restaurant Workers, Chefs And Owners

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The San Francisco Bay Area is known for its love of fine food. It’s also increasingly becoming known as an area where it’s almost impossible to live on a service-industry wage. …

Estudio de seguridad revela el riesgo de coágulos de sangre en los pulmones y muerte con una dosis más alta de tofacitinib (Xeljanz, Xeljanz XR) en pacientes con artritis reumatoide; la FDA investigará

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Estudio de seguridad revela el riesgo de coágulos de sangre en los pulmones y muerte con una dosis más alta de tofacitinib (Xeljanz, Xeljanz XR) en pacientes con artritis reumatoide; la FDA investigará …

La FDA agrega un Recuadro de advertencia por el aumento en el riesgo de muerte con el medicamento para la gota Uloric (febuxostat)

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La FDA agrega un Recuadro de advertencia por el aumento en el riesgo de muerte con el medicamento para la gota Uloric (febuxostat) …

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