🇺🇸 FDA - Fiscal Year 2024 Generic Drug Science and Research Initatives Public Workshop

@trust_user_a @trust_user_b @trust_user_c @trust_user_d

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.

Event information: Fiscal Year 2024 Generic Drug Science and Research Initiatives Public Workshop - 05/20/2024 | FDA

What would you propose?

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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.

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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.

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The event is hybrid, so you should be able to join via zoom as well. As always FDA will provide recordings of the event later

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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.

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Para el caso de la Nitrosaminas, como fabricantes de genéricos, revisar a fondo nuestros productos, desde el agua para la fabricación, hasta el sistema contenedor-cierre. Enfocar la investigación en el proceso integral y hacerlo multidisciplinario, involucrando a todas las áreas que participan en el proceso de fabricación, poner en tanto a todas estas áreas sobre la importancia de identificarlas y monitorearlas, así como de las condiciones en las que estás se presentan.

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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.

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Los “Do” y “Don´t” de los modelos In silico relacionado al tema de impurezas, tales como nitrosaminas

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.

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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.

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I would also like to know this information! Is there an official event schedule yet? :slight_smile: