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

credit: Wingwire


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.
Related Programs

Food and Drug Administration_Research

Department of Health and Human Services


Agency: Food and Drug Administration

Office:

Estimated Funding: $1,000,000


Relevant Nonprofit Program Categories





Obtain Full Opportunity Text:
Full Announcement of RFA-FD-15-036 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:
2015-05-14

Application Due Date:
2015-07-02

Archive Date:
2015-08-01


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