Safety and effectiveness data: Will children gain access?

American Heart Journal

Volumn 136, Issue 1, 1998, Pages 4-5

  Schreiner, M S ^a  

^a CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BETA ADRENERGIC RECEPTOR BLOCKING AGENT; METOPROLOL;

CARDIOMYOPATHY; CLINICAL TRIAL; DEVICE; DRUG EFFICACY; DRUG INDICATION; DRUG INDUSTRY; DRUG LABELING; DRUG SAFETY; EDITORIAL; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ACCESS; HUMAN; PEDIATRICS; PRIORITY JOURNAL;

EID: 0031873432     PISSN: 00028703     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0002-8703(98)70173-5     Document Type: Editorial

References (8)

1. H. Shirkey Editorial comment: Therapeutic orphans Pediatrics 72 1968 119 120
2. JT. Wilson Pragmatic assessment of medicines available for young children and pregnant or breast-feeding women Morsellit Basic and therapeutic aspects of perinatal pharmacology. 1977 Raven Press New York 76 112
3. MJ. Finkel The FDA on “deorphaning” drugs Hastings Center Report 7 3 1977 9
4. Institute of Medicine Drug development and the pediatric population: report of a workshop 1991 National Academy Press Washington
5. American Academy of Pediatrics, Committee on Drugs Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations Pediatrics 95 1995 286 294
6. CJ CotÉ RE Kauffman GJ Troendle GH. Lambert Is the “therapeutic orphan” about to be adopted? Pediatrics 98 1996 118 123
7. Pediatric Patients: regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products; proposed rule Department of Health and Human Services, Food and Drug Administration: 21 CFR Parts 201, 312, 314, and 601 62 158 1997 43899 43916
8. RE. Shaddy β-Blocker therapy in young children with congestive heart failure under consideration for heart transplantation Am Heart J 136 1998 19 21