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FDA urges industry to follow nitrosamine guidance; asked sponsors for progress reports
Summary
At the forum, an FDA presenter reiterated the agency's expectations on nitrosamine mitigation, noting sponsors were asked in August 2025 to submit progress reports and that FDA is reviewing those submissions.
An agency official representing the FDA summarized the agency's ongoing work on nitrosamine impurities and urged manufacturers to evaluate risks, perform confirmatory testing, and implement mitigation strategies when impurities are detected. "FDA and manufacturers share a common goal. We are committed to addressing nitrosamine impurities while ensuring continued patient access to needed medicines," the presenter said.
He told attendees that sponsors were asked in August 2025 to submit progress reports on mitigation strategies and that FDA is currently reviewing the information. The presenter encouraged stakeholders to use established engagement pathways—such as meetings and controlled correspondence—and to participate in forums and workshops where nitrosamine-related challenges can be discussed.
