Therapeutic Solutions International Inc (TSOI)

[BigBadWolf]

Review Time for initial submission of an Investigational New Drug application is 30 days from the date FDA receives the IND. An IND applicant may proceed with a clinical investigation once the applicant has been notified by FDA that the investigation may proceed or after 30 days if the IND is not placed on Clinical Hold.

(b) An IND goes into effect:

(1) Thirty days after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold under § 312.42; or

(2) On earlier notification by FDA that the clinical investigations in the IND may begin. FDA will notify the sponsor in writing of the date it receives the IND.

https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-applications-clinical-investigations-overview

Remember...
Post by TimGDixon » Wed Sep 07, 2022 7:51 am

Well there are timelines and then there are timelines. We would never proceed without clearance as a rule of thumb even if som regulation says no reply in 30 you can proceed. Always better to have them on your side. This is an amendment and so we'll have to let it play out.

https://forum.therapeuticsolutionsint.com/viewtopic.php?t=362&start=15