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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.
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.
Who's Eligible
Obtain Full Opportunity Text:
Full Announcement of RFA-FD-16-004 on NIH Guide for Grants and Contracts
Additional Information of 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.
Full Opportunity Web Address:
Contact:
Agency Email Description:
Agency Email:
lisa.ko@fda.hhs.gov
Date Posted:
2015-07-31
Application Due Date:
2015-10-16
Archive Date:
2015-11-15
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