Food and Drug Administration

Description

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.

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities / Indian housing authorities
• Native American tribal organizations (other than Federally recognized)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others

Contact

Lisa Ko <br/>Grants Management Specialist <br/>
lisa.ko@fda.hhs.gov