ADVERSE DRUG REACTION;
DRUG APPROVAL;
DRUG LABELING;
DRUG MECHANISM;
DRUG SAFETY;
FOOD AND DRUG ADMINISTRATION;
HUMAN;
LETTER;
MEDICINE;
PHYSICIAN;
PRACTICE GUIDELINE;
PRESCRIPTION;
PRIORITY JOURNAL;
PRODUCT SAFETY;
QUANTITATIVE ANALYSIS;
STRUCTURED PRODUCT LABEL;
TABLET FORMULATION;
UNSPECIFIED SIDE EFFECT;
ADVERSE DRUG REACTION REPORTING SYSTEMS;
DRUG LABELING;
EVALUATION STUDIES AS TOPIC;
HUMANS;
PRODUCT SURVEILLANCE, POSTMARKETING;
TOTAL QUALITY MANAGEMENT;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
EID: 79957577277PISSN: 00039926EISSN: 15383679Source Type: Journal DOI: 10.1001/archinternmed.2011.182Document Type: Letter
Requirements on content and format of labeling for human prescription drug and biological products. Final rule
Food and Drug Administration, HHS
Food and Drug Administration, HHS. Requirements on content and format of labeling for human prescription drug and biological products. Final rule. Fed Regist. 2006;71(15):3921-3997.
US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Rockville, MD: Food and Drug Administration
US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products-Content and Format. Rockville, MD: Food and Drug Administration; 2006.
ADESSA: A Real-Time Decision Support Service for Delivery of Semantically Coded Adverse Drug Event Data
Duke JD, Friedlin J. ADESSA: A Real-Time Decision Support Service for Delivery of Semantically Coded Adverse Drug Event Data. AMIA Annu Symp Proc. 2010;2010:177-181.
US National Library of Medicine, Accessed November 14, 2009
US National Library of Medicine. 2008AB National Drug File-Reference Terminology Source Information. 2009. http://www.nlm.nih.gov/research/umls/sourcereleasedocs/2008AB/NDFRT/attributes.html. Accessed November 14, 2009.