It's seems to be an initial registration with the FDA. I know that any company that completes the pre-clinical stage and wants to start clinical trials have to file for a IND (New Drug Application) through the FDA.
from the FDA site:
A publicly traded company, US or foreign stock exchange, is added to the SRO List.............if its research, development, or other business activities are reasonably expected to result in the development of products that are regulated by FDA.
Listing of Significantly Regulated Organizations (SRO), page-2
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