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FDA Orphan Status for Seattle Genetics Drug

[ Price : $8.95]

FDA grants an orphan drug designation to Seattle Genetics Adcetris (brentuximab vedotin) for treating mycosis fungoides.

Alaunus Pharmaceuticals Inspection Results Released

[ Price : $8.95]

FDA releases the FDA-483 from a New England District Office 2012 inspection at Alaunus Pharmaceuticals, associated with New Englan...

Hearing to Discuss Preoperative Skin Product Contamination

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Federal Register Notice: FDA plans a pubic hearing 12/12-13 to discuss microbial contamination of patient preoperative skin prepar...

Patanase Sales Aid Overstates Efficacy: OPDP

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CDERs Office of Prescription Drug Promotion notifies Alcon that a professional sales aid for its Patanase overstates the drugs eff...

Findings from 2 St. Jude Medical Inspections Released

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FDA releases the FDA-483 reports from inspections at St. Jude Medical facilities in Puerto Rico and California.

FDA Significant Delay in Warning NECC

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Reuters reports that it took FDA 684 days to issue a Warning Letter after it has inspected the troubled New England Compounding Ce...

FDA Orphan Status for OxiGene Leukemia Candidate

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FDA grants OxiGene an orphan drug designation for OXi4503 for treating acute myelogenous leukemia.

FDA Approves HeartWare Ventricular Assist System

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FDA approves a HeartWare PMA for its HeartWare Ventricular Assist System, a left ventricular assist device intended for use to sup...

FDA, Dietary Supplement Maker Enter Consent Decree

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A federal judge in Minnesota approves a consent decree between FDA and Pharmacists Ultimate Health for unlawfully distributing una...

FDA Grants Fast Track for Hemophilia A Therapy

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FDA grants Inspiration Biopharmaceuticals fast track status for OBI-1 in acquired hemophilia A.