OpportunityTitle: Post-market Surveillance of Generic Modified Release Products (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 analyze use, substitution patterns, safety and effectiveness of generic modified release products, and compare them with their respective brand name drug products and other generic drugs with different formulation design characteristics. The outcome(s) of this study will help determine if there are differences in the patterns of use, substitution, and safety and effectiveness associated with the studied generic modified release products, and to provide further evidence regarding their substitutability for brand name drugs.
GrantorContactEmailDescription: lisa.ko@fda.hhs.gov
GrantorContactText: Lisa Ko &lt;br/&gt;Grants Management Specialist &lt;br/&gt;