The U.S. Food and Drug Administration (FDA) is urging drug manufacturers to complete risk assessments for nitrosamine impurities by November 16, 2025, following the discovery of a new leachable nitrosamine compound in certain infusion bag products. The call to action underscores the agency’s continued focus on patient safety and product quality in the generic drug sector.
Emerging Concerns Around Nitrosamines
Nitrosamines, classified as potential carcinogens, have remained a key focus for global regulators since their discovery in valsartan products in 2018. The most recent concern involves N-nitrosodibutylamine (NDBA), a small-molecule impurity that may leach from packaging materials such as printed overwraps or nitrocellulose-coated infusion bags into the drug product.
In August 2025, the FDA released an update titled “Emerging Scientific and Technical Information on Leachable NDMA and Other Small-Molecule Nitrosamines in Infusion Bags,” advising manufacturers to conduct thorough risk assessments and test at least three batches of affected products. Findings must be reported to the FDA by the mid-November deadline.
FDA’s Iilun Murphy, Director of the Office of Generic Drugs (OGD), reinforced this message during her remarks at the Association of Accessible Medicines (AAM) GRx+Biosim meeting in Bethesda, MD. Murphy emphasized that proactive testing and transparent reporting are essential to prevent contamination and ensure the continued safety of infusion therapies.
Balancing Compliance and Innovation
While nitrosamine risk mitigation remains a priority, Murphy also highlighted the FDA’s progress in accelerating generic drug approvals. In fiscal year 2025 alone, the agency approved or tentatively approved 939 Abbreviated New Drug Applications (ANDAs), including 125 complex generics and 92 first-time generic approvals. These milestones reflect the FDA’s ongoing efforts to strengthen competition and expand patient access to affordable medicines.
The agency also launched a pilot prioritization program designed to encourage domestic manufacturing and testing. Under this initiative, ANDA applicants who conduct bioequivalence testing in the U.S. and source their Active Pharmaceutical Ingredients (APIs) domestically may qualify for priority review — a move that aligns with national reshoring goals and supply chain resilience.
The Importance of Risk-Based Oversight
Murphy acknowledged that the FDA has extended deadlines for other types of nitrosamine-related impurity testing, allowing manufacturers additional time to complete thorough evaluations. However, she reaffirmed that risk assessments must remain a non-negotiable component of compliance.
This approach reflects a broader shift toward risk-based regulatory oversight, where science-driven assessments help balance safety, efficiency, and innovation. By identifying and mitigating potential impurities early in the product lifecycle, manufacturers can avoid costly delays, protect patients, and build confidence with regulators.
The EMMA International Perspective
At EMMA International, we recognize that proactive risk management is key to maintaining compliance and ensuring product safety. As the FDA continues to enhance its oversight of nitrosamine impurities, manufacturers must integrate robust testing, documentation, and risk assessment strategies into their quality systems.
Our team supports life-science organizations in aligning with FDA and international expectations, offering expertise in contamination control, risk-based quality management, and regulatory submission readiness. With deadlines fast approaching, preparation and data integrity remain essential to meeting FDA’s evolving standards.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference:
- Eglovitch, J. (2025, October 27). FDA’s top generic drug official urges firms to complete nitrosamine risk assessments. Regulatory Affairs Professionals Society.
- U.S. Food and Drug Administration. (2025). Emerging scientific and technical information on leachable NDMA and other small-molecule nitrosamines in infusion bags.
