Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed
ID: 351621Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$0 - $350K

Eligible Applicants

Unrestricted

Funding Category

Food and Nutrition

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/351621

Additional Information

https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-020.html
Timeline
  1. 1
    Forecast Posted Not available
  2. 2
    Forecast Due Not available
  3. 3
    Posted Dec 21, 2023 12:00 AM
  4. 4
    Due Feb 27, 2024 12:00 AM
Description

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), is announcing a Funding Opportunity Announcement (FOA) for a Cooperative Agreement. This opportunity aims to address the issue of nitrosamine impurities in human drugs and improve the safety of these drugs. The proposed work will involve the identification and evaluation of possible approaches to addressing nitrosamine impurities in drugs.

Nitrosamine impurities pose risks to public health, and while significant efforts have been made in this area, further research, development, and refinement of translational and implementable practices are needed. The goal is to protect the public from nitrosamine risks while ensuring continued safe access to critical therapeutic drugs.

In addition to the research and development work, the award recipient will also assess how to ensure the continuation of this research and practices development among industry members, non-profits, and/or academic institutions once the FDA funding for this cooperative agreement ends.

For more information, please refer to the Funding Opportunity Announcement.

Point(s) of Contact
terrin.brown@fda.hhs.gov
Files
No associated files provided.
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