CHILD SAFETY;
DRUG APPROVAL;
DRUG CONTROL;
DRUG EFFICACY;
DRUG FORMULATION;
DRUG INFORMATION;
DRUG LABELING;
DRUG LEGISLATION;
DRUG SAFETY;
DRUG USE;
HUMAN;
LETTER;
PEDIATRICS;
PRIORITY JOURNAL;
EID: 84860734728PISSN: 00987484EISSN: 15383598Source Type: Journal DOI: 10.1001/jama.2012.3435Document Type: Letter
Pragmatic assessment of medicines available for young children and pregnant or breast-feeding women
New York, NY: Raven Press
Wilson JT. Pragmatic assessment of medicines available for young children and pregnant or breast-feeding women. In: Basic and Therapeutic Aspects of Perinatal Pharmacology. New York, NY: Raven Press; 1975:411-421.
US Department of Health and Human Services; Accessed October 10, 2011
US Department of Health and Human Services; Food and Drug Administration. FDA pediatric labeling changes table . http://www.accessdata.fda.gov/scripts/ sda /sdNavigation.cfm?sd=labelingdatabase. Accessed October 10, 2011.
US Department of Health and Human Services; Accessed October 10, 2011
US Department of Health and Human Services; Food and Drug Administration. Guidance for industry: how to comply with the Pediatric Research Equity Act. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess /DevelopmentResources/UCM077855.pdf. Accessed October 10, 2011.
US Department of Health and Human Services; Accessed October 10, 2011
US Department of Health and Human Services; Food and Drug Administration. New molecular entities drug and new biologic approvals. http://www.fda.gov /Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved /DrugandBiologicApprovalReports/ucm121136. Accessed October 10, 2011.