Post-market Surveillance of Generic Modified Release Products (U01)


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.

General information about this opportunity
Last Known Status
Deleted 07/29/2015 (Archived.)
Program Number
Federal Agency/Office
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Type(s) of Assistance Offered
Cooperative Agreement
Number of Awards Available
Who is eligible to apply/benefit from this assistance?
Applicant Eligibility
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.
What is the process for applying and being award this assistance?
Other Assistance Considerations
Formula and Matching Requirements
This program does not have cost sharing or matching requirements.
Who do I contact about this opportunity?
Headquarters Office
Lisa Ko
Grants Management Specialist
Website Address
E-mail Address
Financial Information
Range and Average of Financial Assistance
Awards up to $500,000.00


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