@Nitrosamines_Analyzer @Nitrosamines_Explorer @Nitrosamines_Investigator @Nitrosamines_Mitigator
You don’t want to miss the upcoming FDA GDUFA Workshop…
Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop
June 8 - 9, 2026
Topics discussed during the workshop will focus on research that is needed to address scientific knowledge gaps and associated challenges impacting the development and regulatory assessment of generic products, including complex generics. During the workshop, public input will also be sought on the prioritization of product-specific guidances (PSGs). The sessions of this year’s workshop will focus on identifying what research is needed related to:
- Leveraging Generic Drug Industry Expertise & Insights for GDUFA Research & PSG Prioritization
- Addressing Ongoing Challenges with Impurities such as Nitrosamines
- Expanding Regulatory Flexibility with Bioequivalence Approaches and Standards
- Using Artificial Intelligence (AI) to Address Practical Challenges for Generic Drug Development and Regulatory Assessment
- Standardizing Characterization Test Methods Supporting Bioequivalence and Product Quality
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Thanks for the reminder! This is coming up very soon and includes a number of fantastic speakers.
Updated link for those who need it below. Day 1 is going
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We are present at the FDA GDUFA Science and Research public workshop!
Materials and Presentations…
brought to you frist by Nitrosamine Exchange (Jeje!)
https://fdahhs.ent.box.com/s/6dv114igq0x3bmfz9xaqktq1zxhuyp98/folder/387617562355
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That was a really interesting note from Valerie Niddam-Hildesheim. Due to the timeline to reformulate products and prioritization, it may take 10 years to get a portfolio into compliance, leading some products to be discontinued.
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I would also highlight the presentation from Dr. Flip De Bock. It clearly emphasized that the assessment needs to be performed on a case-by-case basis.
In particular, the observed nitrosamine formation at pH 9 was quite striking, as well as the level of uncertainty associated with modified-release reformulations.
Last but not least, the reconfirmation that NOx can be a relevant contributor. I could also confirm that is the case.
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Im glad to see Dr Simonian speaking on the analytical challenges … many time they are as complex as in the manufacturing or formulation suite.
Happy to see the enhanced approach to analytical development and validation of the nitrosamines testing.
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Enjoying Dr Ulrich presentation on excipients… and his report on where they have NOT found nitrites!
Comprehensive and sistematic approach to mitigation strategy development
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@conudel Dr. Nudelman advising us on what will take us to understand the n-nitro compounds beyond Nitrosamines…
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3 year roadmap for the HESI o-NNO working group
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Looks like they locked the access to these
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I led a study that was really similar, but solid state. At 50°C/60%RH, a similar time was needed. There are a lot of little details to work out.
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These represent the next logical questions. While it is unlikely that this will evolve into a crisis comparable to that of N-nitrosamines, should it be addressed proactively, or should a clearly defined framework be established first? However, you could not have a framework without experimentation first. For me, from a purely scientific and personal perspective, it is better to over the learning curve.
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Gracias Naiffer, muy útil.
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I believe everyone can access but not download the files…
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Thanks. Yes, they are now available again.
Hi everyone,
Is there any link to access those very interesting presentations as it was very difficult to participate on-line due to time difference?
Christos
