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Biology / Peptide hormones / Recombinant proteins / Eli Lilly and Company / Insulin aspart / Insulin pump / Insulin analog / Insulin / Diabetes management / Diabetes / Endocrine system / Medicine


Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology
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Company

Deputy Director Lanh Green Pharm / CDER Kellie Taylor Pharm / Novo Nordisk Inc. / Quocbao Pham Pharm / /

Country

United States / /

Event

FDA Phase / Product Issues / /

IndustryTerm

food allergies / injection site / pen device / similar search / delivery pen device / pen devices / insulin product / insulin products / /

MedicalCondition

unrecognized diabetic ketoacidosis / palsy / neonatal / multiple congenital abnormalities / seizures / hypoglycemic seizures / congenital abnormalities / Pediatr Diabetes / hives / hypospadia sine hypospadia / respiratory distress syndrome / coma / pruritis / skin rash / alopecia / streptococcal pharyngitis / severe diabetic ketoacidosis / Treatment Described Event Suspected Cause Hyperglycemia / food allergies / reductase deficiency / diabetic ketoacidosis / bradycardia / hypersensitivity / equinovarus / MS / hypoglycemia / Insulin Resistance / spina bifida / disease / tooth abscess / acute lymphocytic leukemia / splenic malformation syndrome / Hyperglycemia / fecal incontinence / diabetes / erythema / atelectasis / caudal regression syndrome / seizure / vomiting / idiopathic thrombocytopenia purpura / hypoxiaischemic encephalopathy / both hyperglycemia / inguinal hernia / diabetes mellitus / urticaria / hypoxic encephalopathy / fetal death / Ludvigsson J. Hypoglycemia / foetal distress syndrome / Polydactyly / infection / severe hypoglycemia / repeated injection site urticaria / rash / epileptic seizures / /

MedicalTreatment

medication errors / antibiotics / insulin delivery / renal transplant / insulin pump / /

OperatingSystem

OSE / /

Organization

Urgent Care Center / office of New Drugs / office of Surveillance and Epidemiology / Pediatric Advisory Committee / Safety Evaluator Division of Medication Error Prevention / Team Leader Division of Pharmacovigilance / office of Pediatric Therapeutics / Analysis office of Surveillance and Epidemiology / Research office of Surveillance and Epidemiology Date / Director office of Pediatric Therapeutics / Safety Evaluator Division of Pharmacovigilance / Division of Medication Error Prevention / Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation / FDA / Physician Office / Medication Error Prevention and Analysis office of Surveillance and Epidemiology / /

Person

Judy Park / Lisa L. Mathis / Recovered Overall / Ann W. McMahon / Carol Holquist / M. Dianne Murphy / /

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Position

physician / Director / Associate Director / reporter / Director Pediatric and Maternal Health Staff / /

Product

NovoLog / topiramate / Novolin N / batch / NovoLogĀ® / /

Technology

alpha / Antibodies / /

SocialTag