CASE REPORT;
CHILD CARE;
CONFERENCE PAPER;
DOSE CALCULATION;
DRUG INDICATION;
DRUG LABELING;
DRUG LEGISLATION;
DRUG UTILIZATION;
FOOD AND DRUG ADMINISTRATION;
GASTROESOPHAGEAL REFLUX;
HUMAN;
INFANT;
LUNG DYSPLASIA;
LYMPHEDEMA;
MALE;
PRACTICE GUIDELINE;
PREMATURITY;
PRESCRIPTION;
PRIORITY JOURNAL;
RESPIRATORY ARREST;
RESPIRATORY DISTRESS;
ALBUTEROL;
ANTI-ULCER AGENTS;
BRONCHODILATOR AGENTS;
CATHETERIZATION, PERIPHERAL;
DIAZEPAM;
DRUG APPROVAL;
DRUG LABELING;
DRUG UTILIZATION;
FEMALE;
HUMANS;
HYPNOTICS AND SEDATIVES;
INFANT;
LEGISLATION, DRUG;
MALE;
PEDIATRICS;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
Unapproved uses of approved drugs: The physician, the package insert and the Food and Drug Administration: Subject review
American Academy of Pediatrics, Committee on Drugs. Unapproved uses of approved drugs: the physician, the package insert and the Food and Drug Administration: subject review. Pediatrics. 1996;98:143-145
Specific requirements on contract and format of labeling for human prescription drugs: Revision of "pediatric use" subsection in the labeling; final rule, tuesday, December 13, 1994. Part II
Department of Health and Human Services Food and Drug Administration. 21 CFR Part 201
Specific requirements on contract and format of labeling for human prescription drugs: revision of "pediatric use" subsection in the labeling; Final Rule, Tuesday, December 13, 1994. Part II. Department of Health and Human Services Food and Drug Administration. Federal Register. 21 CFR Part 201:
Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations
American Academy of Pediatrics, Committee on Drugs. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics. 1995;95:286-294
Research involving children: Recommendations of the National Commission for Protection of Human Subjects in Biomedical and Behavioral Research
Jansen AR. Research involving children: recommendations of the National Commission for Protection of Human Subjects in Biomedical and Behavioral Research. Pediatrics. 1978;62:131-136
