Development of Advanced Analytical Methods for the Characterization of Iron Carbohydrate Complex - Ferric Derisomaltose (U01) Clinical Trials Not Allowed
The summary for the Development of Advanced Analytical Methods for the Characterization of Iron Carbohydrate Complex - Ferric Derisomaltose (U01) Clinical Trials Not Allowed grant is detailed below.
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Development of Advanced Analytical Methods for the Characterization of Iron Carbohydrate Complex - Ferric Derisomaltose (U01) Clinical Trials Not Allowed: Development of advanced analytical methods for the characterization and comparative analysis of complex products are important for linking product attributes to safety, quality and clinical performance, which is helpful for facilitating development of generic complex products. The purpose of this study is to develop advanced analytical methods for the characterization and analysis of ferric derisomaltose which is a complex drug product. The results from this study will help the development and review of generic ferric derisomaltose.
| Federal Grant Title: | Development of Advanced Analytical Methods for the Characterization of Iron Carbohydrate Complex - Ferric Derisomaltose (U01) Clinical Trials Not Allowed |
| Federal Agency Name: | Food and Drug Administration (HHS-FDA) |
| Grant Categories: | Consumer Protection Food and Nutrition Science and Technology |
| Type of Opportunity: | Discretionary |
| Funding Opportunity Number: | RFA-FD-21-016 |
| Type of Funding: | Cooperative Agreement |
| CFDA Numbers: | 93.103 |
| CFDA Descriptions: | Information not provided |
| Current Application Deadline: | March 31st, 2021 |
| Original Application Deadline: | March 31st, 2021 |
| Posted Date: | January 7th, 2021 |
| Creation Date: | January 7th, 2021 |
| Archive Date: | April 30th, 2021 |
| Total Program Funding: | |
| Maximum Federal Grant Award: | $600,000 |
| Minimum Federal Grant Award: | $300,000 |
| Expected Number of Awards: | 1 |
| Cost Sharing or Matching: | No |
| Last Updated: | January 7th, 2021 |
- Applicants Eligible for this Grant
- 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 tribal governments) - 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 - Private institutions of higher education - For-profit organizations other than small businesses - Small businesses - Others (see text field entitled "Additional Information on Eligibility" for clarification.)
- Additional Information on Eligibility
- Eligible Organizations Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations Small Businesses For-Profit Organizations (Other than Small Businesses) Governments State Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession Other Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions)
- Link to Full Grant Announcement
- FULL ANNOUNCEMENT - RFA-FD-21-016
- Grant Announcement Contact
- Shashi Malhotra
Grants Management Specialist
Phone 2404027592
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