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Re: dr_lowenstein post# 544935

Tuesday, 12/06/2022 9:20:02 PM

Tuesday, December 06, 2022 9:20:02 PM

Post# of 708294
Thank you for asking!

FDA Guidance September 2022

https://www.fda.gov/media/124795/download


There are lots of recent publications referring to the regulatory evolution toward better and more feasible trial designs.

https://media.nature.com/original/magazine-assets/d41573-020-00146-5/d41573-020-00146-5.pdf

https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext

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