Building towards Statistically-Based Pharmaceutical Quality Standards (U01)


The goal of this project is to generate data and develop a statistical sampling and analysis strategy to aid FDA/CDER policy in drafting data-based guidance in support of the use of appropriate statistical tools and standards. Specifically, the development of standards for statistical methods suitable for lot release which could be used to drive industry towards increased product and process understanding throughout the lifecycle of a product. The project will provide data, sampling and data analysis approaches to inform for the agency and the human pharmaceutical industry to advance the development of risk- and science-based standards. These projects could be split into subsets by product type, process type, manufacturing complexity and/or therapeutic index to facilitate understanding.

General information about this opportunity
Last Known Status
Deleted 11/15/2015 (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 $1,000,000.00


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