View Document Preview and Link Open Document File Size: 1,06 MB Share Result on Facebook
City Reference / / Company AEs / INO Therapeutics LLC / ITT / / Continent Europe / / Country United States / / Event FDA Phase / Product Recall / Product Issues / / IndustryTerm prevention of chronic lung disease / treatment / inhaled nitric oxide product / treatment groups / placebo / study protocol / / MedicalCondition Bronchopulmonary Dysplasia / multiple abnormalities / premature birth / methemoglobinemia and elevated nitrogen dioxide concentrations / respiratory illness / congenital heart disease / respiratory failure / patent ductus arteriosus / congenital·diaphragmatic hernia / chronic / pulmonary angiogenesis / pulmonary hypertension / retinopathy of prematurity / pulmonary / lung disease / chronic lung disease / respiratory insufficiency / hypoxic respiratory failure / Chorioamnionitis / atrial septal defect / respiratory distress / / MedicalTreatment nasal continuous positive airway pressure / cannula / extracorporeal membrane oxygenation / mechanical ventilation / / Organization Division of Cardiovascular and Renal Products / Division of Pulmonary / Allergy / and Rheumatology Products / Pediatric Exclusivity Board / FDA / MEDICAL OFFICER REVIEW Division of Pulmonary / Allergy and Rheumatology Drug Products / / Person Buenconsejo / Clinton / Apgar / Anthony Durmowicz / K. Witzmann / Disallowed Therapies Subjects / / / Position Investigator / Medical Team Leader / / Product INOmax / Consent / INOT27 / O2 / Rheumatology Drug / / ProvinceOrState Georgia / / Technology alpha / study protocol / x-ray / ultrasound / specific protocol / / SocialTag 
20845 Nitric Oxide Clinical PREA