Ann: Neurizon Files IND Application to Support HEALEY ALS Trial, page-72

Here is some stuff I come across, one from someone who has submitted a few INDs.


So, I don’t work in govt but I do interact with FDA and compile and submit a few Investigational New Drug (IND) applications every year. They’re typically about 4k-6k pages (all electronic now, ofc).

The average number of pages in an Investigational New Drug (IND) submission to the FDA can vary significantly depending on the complexity of the drug, the extent of the preclinical data, and the phase of clinical investigation. However, based on available information, typical IND submissions can range from 4,000 to 6,000 pages, particularly when they are all electronic submissions.


Cheers