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Re: loanranger post# 255477

Monday, 02/04/2019 1:09:10 PM

Monday, February 04, 2019 1:09:10 PM

Post# of 403022
A Little comment here on that linked message.

1. Easiness of approval, if defined as more lax rules, is questionable. There is not much difference in regulations between US, EU, Australia, Canada and Japan - countries where pharma makes most of its profits.
2. That NJ company may have registered their innovation first in another country for several reasons. One being that their trials were non-IND, were done outside US and did not satisfy FDA's conditions for approvability in US. For instance: A company can forget US registration if either of below conditions are not met:

A. Study was conducted in accordance with Good Clinical Practice (GCP)
B. FDA is able to validate the data from the study through an onsite inspection

sources:
https://www.fda.gov/downloads/drugs/newsevents/ucm441250.pdf
https://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm124939.pdf

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