Generic Drug Substitution in Special Populations (U01)

The purpose of this study is to: 1) collect information on practice patterns in special populations to assess possible barriers to generic substitution ; 2) compare clinical practice (e.g., drug product manipulation prior to administration, co-administration with another food or drug) with labeled drug administration information in the assessed populations to identify factors that raise issues for safety and effectiveness with generic substitution; and 3) analyze the impact of product-level, patient-level, and provider-level factors on generic drug substitution. The outcome of this study will help identify research needs, support FDA’s regulatory science efforts to monitor and ensure successful generic substitution, and provide evidence to assure the public on generic drug safety and effectiveness.