---
title: "FDA Deadline Update - Risk of nitrosamine drug substance-related impurity (NDSRI)"
description: "On June 23, 2025, the FDA released a clarification regarding the upcoming August 1, 2025 deadline related to nitrosamine drug substance-related impurities (NDSRIs)."
url: https://qbdgroup.com/en/regulatory-updates/fda-deadline-update-risk-of-nitrosamine-drug-substance-related-impurity
type: "Regulatory update"
language: en
published: 2025-07-01
author: "Pablo Palomar, Senior Toxicology Officer"
category: "Regulatory Affairs"
publisher: "QbD Group"
citation: "QbD Group, \"FDA Deadline Update - Risk of nitrosamine drug substance-related impurity (NDSRI)\", https://qbdgroup.com/en/regulatory-updates/fda-deadline-update-risk-of-nitrosamine-drug-substance-related-impurity"
---
# FDA Deadline Update - Risk of nitrosamine drug substance-related impurity (NDSRI)
> On June 23, 2025, the FDA released a clarification regarding the upcoming August 1, 2025 deadline related to nitrosamine drug substance-related impurities (NDSRIs).

## Key takeaways from the update:

- **Confirmatory testing and risk evaluation** must still be completed by August 1, 2025. This deadline remains unchanged.
- **CMC changes:** While previously expected by the same date, the FDA now acknowledges that many mitigation strategies may require more time. **If companies cannot submit full changes by August 1, they are now required to submit a progress update instead**. Progress update should include specific content as outlined in the recommendations published by the FDA update. This ensures transparency and accountability while allowing more time for complex implementation work.

## What's next?

After reviewing the submitted progress updates, the FDA will provide a revised targeted timeline for full implementation.

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---
Source: https://qbdgroup.com/en/regulatory-updates/fda-deadline-update-risk-of-nitrosamine-drug-substance-related-impurity — © QbD Group. Quote freely with attribution and a link back.