Regulatory Open Forum

Hello, I was wondering if any one has a module 2, specifically 2.7.3 document they would be willing to share with me? I am fairly new to regulatory writing and was hoping to find some templates on TransCelerate but they do not have any for CTDs. Thank you.

Hi Erica ~

I don't know of publicly available CTD templates; however, the ICH/FDA M4 Efficacy Guidance document has a detailed content outline for all of the Module 2 Clinical summary documents that you should be able to use to build a document in Word: (https://www.fda.gov/media/93569/download

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Patrick Thomas
Collegeville PA
United States
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