On May 20-21 FDA will host an in-person & hybrid workshop at the FDA Whtie Oak Campus. and Nitrosamines Exchange will be there…
The public workshop aims to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from the generic drug industry, academia, patient advocates, professional societies, and other interested parties as it fulfills its commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to develop an annual list of science and research initiatives specific to generic drugs. FDA will consider the information from the public workshop when developing its Fiscal Year (FY) 2025 Generic Drug User Fee Amendments (GDUFA) science and research priorities.
Topics discussed during the workshop will focus on research needed to address scientific knowledge gaps and associated challenges impacting generic product development and regulatory assessment, including complex generics. Sessions of the FY 2024 GDUFA Public Workshop will facilitate public input on research needs for generic products, including those related to:
Nitrosamine Drug Substance-Related Impurities
Drug-Device Combination Products
Predictive Tools to Improve the Efficiency of Generic Product Development
Other Research Needed to Address GDUFA III Science & Research Priority Initiatives
FDA is seeking ideas on research topics for FY2025 GDUFA Science and Research Priorities. submitting a comment on the public docket (FDA-2023-N-0119) on or before 11:59 p.m. Eastern Time at the end of June 21, 2024.
In the pursuit of advancing generic drug development, it is imperative to emphasize predictive tools that harness the wealth of publicly available data while minimizing reliance on animal studies.
Additionally, I’d like to add a topic regarding analytical challenges, spanning from sample preparation to the analysis itself.
Hi,
More emphasis should be given on the predictive tools for generic drug product development and also on the drug-device combination. I would like to recommend to add online mode also for the workshop for the maximum reach and benefits.
Nitrites in excipients are one of the main contributors to the formation of NDSRI in drug formulations. The development of reliable methods for the determination of nitrites in excipients and its inclusion in the USP-NF monographs would encourage excipient manufacturers to focus on this problem.
Would love to see more on the potential role of scavengers within formulations.
There were several papers produced a while ago now, but I haven’t seen anything recently.
Those papers, including from the USP, suggested several potential different scavengers, and provided some data as to the effectiveness, but it was quite inconclusive. Some scavengers seemed to work better in solution than they did in actual products, and it appeared that scavengers that would work for one molecule was not as effective for a different molecule.
Several of the scavengers weren’t on the FDA list of approved excipients, and so while they showed promise in cases they can’t easily be used in a finished product.
There are many more potential scavenger molecules out there that could be used, and help develop a better understanding of the mechanisms (nitrite scavenging or anti-oxidant etc.) and guide people towards selecting the right scavenger for their molecule(s) and product format.
Because the NDSRI list by the FDA includes both possible and impossible nitrosamines, I want to classify them as appropriate. If there are rules similar to CPCA, it would help us. The in-silico prediction is also good.
It would be interesting to also evaluate other sources of nitrosating agents, for example NOx present in the air, which could mean a source with a cumulative effect from the fractionation stage to packaging.
Will the topic of nitrosamines be discussed throughout both days of the workshop or only on the first half of Day 1? Where could I get this information? Couldn’t find it on the FDA’s page.
Lucas, Sarvesh, Jaume, Mark, Luz, Yosuke, Martha, Angel, and Gregory, Thank you for your thoughts and reflections…
It is a humble opportunity and a significant step for our community! Workshop organizers have asked me to present USP Nitrosamines Exchange Experience and Challenges during the Nitrosamine discussion. This is a unique opportunity to raise the Nitrosamines Exchange’s voice as an essential aspect of our vibrant communities. I will be honored to present the challenges, ideas, and opportunities that emerge in our daily discussion with 4,500 community members!
Please keep sending your ideas and thoughts. You can always post it here annonimously or by direct messaging me.
Photocarcinogenicity risk assessment to nitrosamines is valid point to bring in for regulatory risk assessment. However, i understand, this could be more relevant to dermal perspective or nitrosamines that has good systemic circulation and accumulated in skin on repeated administration.
N-nitroso morpholine is one such instance we have encountered.
My suggestion is to have first screening to have for any nitrosamine before it goes for labelling:
Does it have triggering point to absorb photons and trigger phototoxicity?
Does it have potential systemic bioavailability and accumulate in skin to trigger skin cancer?
With the current drugs having nitrosamines at scant levels…I doubt they will be of huge concern for photomutagenicity driven cancer. But i do not mean this is completely negligible risk!
Who could be more suitable than you to take on this presentation? From day one, you’ve been deeply engaged in the intricacies of this group, participating in discussions, raising awareness, offering guidance, and more. You will represent us flawlessly. Much confidence in you.
We had our last planning meeting today, and I want to once again encourage everybody to participate. The public comments presentations and the lineup of speakers promise to bring a very insightful discussion.
