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Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed
The Food and Drug Administration's (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), is announcing this Funding Opportunity Announcement (FOA) for a Cooperative Agreement.The proposed work directly supports the U. S. FDA’s stated goal of protecting public health
from unacceptable risks from nitrosamine impurities in human drugs.
Although significant experimental and policy/regulatory initiatives have been undertaken in this area, there remains a need for further research into and development and refinement of translational and implementable practices that will protect the public against nitrosamine risks while ensuring continued safe access to critical therapeutic drugs.
The aim is to improve the safety of human drugs with potential nitrosamine impurity liabilities.
In addition to the work outlined above, the award recipient will assess how best to ensure that this research and practices development continues among industry members, non-profits, and/or academic institutions once the FDA funding for this cooperative agreement ends.
Although significant experimental and policy/regulatory initiatives have been undertaken in this area, there remains a need for further research into and development and refinement of translational and implementable practices that will protect the public against nitrosamine risks while ensuring continued safe access to critical therapeutic drugs.
The aim is to improve the safety of human drugs with potential nitrosamine impurity liabilities.
In addition to the work outlined above, the award recipient will assess how best to ensure that this research and practices development continues among industry members, non-profits, and/or academic institutions once the FDA funding for this cooperative agreement ends.
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Estimated Funding: $350,000
Office: Food and Drug Administration
Estimated Funding: $350,000
Who's Eligible
Obtain Full Opportunity Text:
https://grants.nih.gov/grants/guide/pa-files/PAR-24-083.html
Additional Information of Eligibility:
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U. S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U. S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Full Opportunity Web Address:
http://grants.nih.gov/grants/guide/pa-files/PAR-24-083.html
Contact:
Agency Email Description:
terrin.brown@fda.hhs.gov
Agency Email:
Date Posted:
2023-12-21
Application Due Date:
Archive Date:
2024-03-28
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