Evaluating Quality Metrics for Risk-Based Surveillance of Drug Manufacturing Operations and Facilities (U01)
The goal of this project is to evaluate a set of potential quality metrics for their utility in monitoring quality across the pharmaceutical manufacturing sector. This project aids to support FDA's efforts in transforming quality oversight from a qualitative to a quantitative and expertise-based assessment in order to assure that quality drugs are available to the American public. The outcomes of the project could also be used to assist in the development of a risk-based inspection approach for domestic and foreign drug establishments.
General information about this opportunity
Last Known Status
Deleted 11/15/2015 (Archived.)
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Type(s) of Assistance Offered
Number of Awards Available
Who is eligible to apply/benefit from this assistance?
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?
Grants Management Specialist
Range and Average of Financial Assistance
Awards up to $500,000.00