Enhancing Regulatory Science for the Risk Based Quality Assessment of Complex Products (U01) - Clinical Trials Optional
ArchivedFood and Drug Administration
Description
The purpose of this program is to support research activities that expand the knowledge base related to complex products and formulation development, analysis, and manufacturing control to advance risk-based quality assessment of new and generic drug products. We will also consider biological products relevant to CDER (e.g., monoclonal antibodies and therapeutic proteins) for this announcement.
Who can apply
- State governments
- Special district governments
- 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
- Small businesses
- Others
Contact
Shashi Malhotra <br/>Grants Management Specialist <br/>Phone 2404027592
shashi.malhotra@fda.hhs.gov
- PostedFeb 13, 2019
- ClosesApr 22, 2019
- Award floor$1,000,000
- Award ceiling$3,000,000
- Program funding$6,000,000
- Expected awards2
- CFDA93.103
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