Building towards Statistically-Based Pharmaceutical Quality Standards (U01)
The summary for the Building towards Statistically-Based Pharmaceutical Quality Standards (U01) grant is detailed below.
This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants.
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If any section is incomplete, please visit the website for the Food Drug Administration, which is the U.S. government agency offering this grant.
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.
Federal Grant Title: | Building towards Statistically-Based Pharmaceutical Quality Standards (U01) |
Federal Agency Name: | Food Drug Administration |
Grant Categories: | Consumer Protection Food and Nutrition Health |
Type of Opportunity: | Discretionary |
Funding Opportunity Number: | RFA-FD-16-003 |
Type of Funding: | Cooperative Agreement |
CFDA Numbers: | 93.103 |
CFDA Descriptions: | Food and Drug Administration_Research |
Current Application Deadline: | Oct 16, 2015 |
Original Application Deadline: | Oct 16, 2015 |
Posted Date: | Jul 31, 2015 |
Creation Date: | Jul 31, 2015 |
Archive Date: | Nov 15, 2015 |
Total Program Funding: | $2,000,000 |
Maximum Federal Grant Award: | $1,000,000 |
Minimum Federal Grant Award: | none |
Expected Number of Awards: | 2 |
Cost Sharing or Matching: | No |
- Applicants Eligible for this Grant
- County governments
City or township governments
Public housing authorities/Indian housing authorities
Native American tribal governments (Federally recognized)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Independent school districts
Native American tribal organizations (other than Federally recognized tribal governments)
State governments
Special district governments
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Private institutions of higher education
Small businesses
For profit organizations other than small businesses
Public and State controlled institutions of higher education - Additional Information on 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. - Link to Full Grant Announcement
- Full Announcement of RFA-FD-16-003 on NIH Guide for Grants and Contracts
- Grant Announcement Contact
- Lisa Ko
Grants Management Specialist
[email protected]
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