Deputy Director Lanh Green Pharm / Usec / PHARMACEUTICA LS INC / Concur / Ferring Pharmaceuticals INC. / Quocbao Pham Pharm / /
Country
United States / /
Event
FDA Phase / /
IndustryTerm
computer search program1 / desmopressin nasal spray products / searched using a customized computer search program1 / /
MedicalCondition
loss of consciousness / seizures / diabetes insipidus / water intoxication / patient’s thrombosis / coma / resultant seizures / primary nocturnal enuresis / hyponatremia / nocturnal enuresis / patient experienced severe stomach aches / hyponatremia and hyperosmolar urine / partial complex seizures / histiocytosis / central diabetes insipidus / arrhythmia / Aggravated Tumor / extrasystoles / tumor / patient experienced headaches / oliguria and elevated urine density / hyponatremic seizures / NE Hallucinations / Oliguria / seizure / experienced auditory and visual hallucinations / vomiting / stupor / emotional disorders / High blood pressure / thrombosis / depression / moderate behavior disorder / /
MedicalTreatment
catheter / /
OperatingSystem
OSE / /
Organization
office of New Drugs / office of Surveillance and Epidemiology / Pediatric Advisory Committee / Team Leader Division of Pharmacovigilance / office of Pediatric Therapeutics / Research office of Surveillance and Epidemiology Date / Director office of Pediatric Therapeutics / Safety Evaluator Division of Pharmacovigilance / Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation / U.S. Food and Drug Administration / FDA / /
Person
Lisa L. Mathis / Ann McMahon / M. Dianne Murphy / ANN WARD W MCMAHON / /
Position
Governor / Associate Director / Director Pediatric and Maternal Health Staff / /
Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology