Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)

About this grant

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 fu Grant Number: FOR-FD-24-008. Expected awards: 1.

Eligibility requirements

All of the following criteria must be met:

• Applicant organizations may submit more than one application, provided that each application is scientifically distinct.The FDA will not accept duplicate or highly overlapping applications under review at the same time. This means that the FDA will not accept:•A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmissio
• Grant Number: FOR-FD-24-008

What the funding covers

• Award Range: $3,50,000 to $3,50,000
• Expected Number of Awards: 1

How to apply

1. 1Applications must be submitted through grants.gov
2. 2Grant Number: FOR-FD-24-008
3. 3Posted: 2023-11-24

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