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CTSI IND Submission template 7-08-2019

20993-0002 RE: New IND Application Submission Dear Reviewers, Pursuant to 21 CFR 312, I am submitting an original, Sponsor-Investigator Investigational New Drug (IND

CTSI IND Submission template 1-4-2019

to include the following: (i) If the investigational drug has been investigated or marketed previously, either in the United States or other countries, detailed information about

CTSI IND Submission template 1-28-2019

20993-0002 RE: New IND Application Submission Dear Reviewers, Pursuant to 21 CFR 312, I am submitting an original, Sponsor-Investigator Investigational New Drug (IND

Support Research

carefully demonstrated in ”real” populations. Such testing has to be done very carefully in well planned clinical studies. Phase I studies check the safety first by a closely monitored

CTSA HUB FACILITIES AND RESOURCES_for web

diagnostic methods and procedures. The Dental Clinical Research Unit has the capability to direct phase I, II, and III trials complete with microbiological analysis. Investigators