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  • 1.  Removing a formulation from an IND - risks

    Posted 25-Jun-2019 11:05
    Hello, 

    I'm interested to hear your thoughts regarding the removal of an old formulation of a tablet (used in early phase clinical trials) from an IND, and the risks of doing so from the FDA's perspective. If one has received assurances that this formulation will not be used in future studies, and there are currently no ongoing studies using that formulation, I think it would be considered low risk.

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    Laura Morley
    Senior Regulatory Affairs Associate CMC
    Foster City CA
    United States
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  • 2.  RE: Removing a formulation from an IND - risks

    Posted 26-Jun-2019 03:13
    I guess it depends on why the formulation was discontinued. It could be an important part of the pharmaceutical development history that could explain differences in PK or safety between the early and later studies. If the change was to got, for example, from powder filled capsules to a compressed tablet and there was no change in dissolution or bioavailability, then there is probably little risk of no longer including the formulation details.

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    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    Jersey City NJ
    United States
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    Original Message


  • 3.  RE: Removing a formulation from an IND - risks

    Posted 26-Jun-2019 08:04
    ​I'm not quite sure what you mean by "removing" it from the IND. And I'm also not sure why you would feel the need to do so. I've only worked in biotechnology products & vaccines, so maybe there's something I'm missing for NCEs, but we've changed formulations but not removed anything from the IND about the previous one. We just don't provide any new information on batches with the old formulation. As the previous poster said, it's all part of the development history.

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    Rachel Thornton
    Associate Director
    Smyrna GA
    United States
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    Original Message


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