biological products / prescription drug products / human biological products / human drug products / medicinal product / non-prescription drug product / cellular and tissue-based products / /
MedicalCondition
LLT Rash / Rash / /
Organization
U.S. Department of Health and Human Services / MedDRA PT / office of Communication / Outreach and Development / Food and Drug Administration Center for Drug Evaluation and Research / MedDRA LLT / FDA / Center for Biologics Evaluation and Research / /
Person
Reaction / Roger Goetsch / / /
Position
original reporter / Governor / FAERS coordinator / FAERS electronic submission coordinator / Data Identifiable patient Identifiable reporter / /
5161 Specifications 508 FINAL Version 1.4.doc