FDA’s White Oak Campus / Element Bldg. / FDA White Oak Campus / /
IndustryTerm
treatment protocol / /
MedicalCondition
ultimately respiratory and cardiac failure / Duchenne Muscular Dystrophy / Inborn Errors of Metabolism / inflammation / fibrosis / /
MedicalTreatment
treatment protocol / /
Organization
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration / Division of Gastroenterology / National Institute of Health / Comments AGENCY / Food and Drug Administration / Pediatric Therapeutics Public Workshop AGENCY / Division of Freedom of Information / Division of Pediatric and Maternal Health / Division of Dockets Management / office of Pediatric Therapeutics / Gastroenterology and Inborn Errors Products Division / FDA / office of Management Programs / Center for Drug Evaluation and Research / NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Measuring Dystrophin / /
[removed]Federal Register / Vol. 80, No[removed]Tuesday, March 3, [removed]Notices TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1—Continued[removed]b), Number of submissions to FDA of ‘‘supporting informati