[Vp-integration-subgroup] [Vp-reproduce-subgroup] Fwd: Update: Draft Guidance: Assessing Credibility of Computational Modeling and Simulation

[John Rice]

Would not even try to incorporate this new draft in our paper thinking.  

But many of you are or will become stakeholders in the process statutorily empowered regulators are or will be using “computational modeling” and other quantitative bioscience in the approval processes including full scale clinical trials.  It behoves you to engage now while the kind of thinking that went into the paper can effect the future use of models and modeling.  Understand the need to focus most of your time on seeking funding but, engaging with regulators now may open new path to applied research. 

John

On Jan 27, 2022, at 22:37, Jacob Barhak <jacob.barhak at gmail.com> wrote:


Greetings reproducibility and integration groups,

John Rice has sent this message. about the FDA document:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions

And indeed this is relevant to our work - in fact this was my suggestion for the next activity. 

FDA has released a request for comments for a document drafted. We actually referred to this document in our paper. 

I was planning to start a discussion on this paper so we can submit responses, either individually or as a group or sub-groups after we finish with the paper.

Yet since the paper is almost done and time is running short, it is perhaps a good idea to discuss this now.

Looking forward to your feedback.

               Jacob


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