pharmaceutical forms / pharmaceutical dosage forms / pharmaceutical dosage / pharmaceutical / /
MedicalCondition
allergic reaction / allergies / Drug hypersensitivity / Disease / allergy / drug allergy / patient's drug allergy / /
MedicalTreatment
antibiotics / /
Organization
U.S. Department of Health and Human Services / Food and Drug Administration Center for Drug Evaluation and Research / Training and Communication Division of Drug Information / Food and Drug Administration / office of Training / HFD-240 Center for Drug Evaluation / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / European Union / ICH Steering Committee / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / office of Communication / Training and Manufacturers Assistance / / /
Position
medically trained reporter and evaluator / evaluator / reporter and evaluator / reporter / /
Guidance for Industry E2B(M): Data Elements for Transmission of Individual Case Safety Reports: Questions and Answers