OpportunityTitle: Generic Drug Substitution in Special Populations (U01)
AdditionalInformationOnEligibility: Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.  Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.  Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
Description: 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&#8217;s regulatory science efforts to monitor and ensure successful generic substitution, and provide evidence to assure the public on generic drug safety and effectiveness.
GrantorContactEmailDescription: eric.bozoian@fda.hhs.gov
GrantorContactText: Eric Bozoian &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027623