Clinical Trials Education Lecture Series

19 February 2004

Investigational New Drug Filing

Bruce F. Kimler, Ph.D.
Professor
Department of Radiation Oncology

Main Page for Food and Drug Administration
http://www.fda.gov

Center for Drug Evaluation and Research
http://www.fda.gov/cder/

Drug Applications
http://www.fda.gov/cder/regulatory/applications/default.htm

Investigational New Drug (IND) Application
http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm

          Introduction
          http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm#Introduction

                   Three types of applications

                   Interactive Chart
                   http://www.fda.gov/cder/handbook/ind.htm

                   Pre-IND Consultation Program
                   http://www.fda.gov/cder/ode4/preind/default.htm

                   Content and Format for INDs for Phase I Studies
                   http://www.fda.gov/cder/guidance/phase1.pdf

                   Exemptions of Marketed Drugs for Treatment of Cancer
                   http://www.fda.gov/cder/guidance/6036fnl.pdf

          Information for Clinical Investigators
          http://www.fda.gov/cder/about/smallbiz/clinical_investigator.htm

                   General Information
                   http://www.fda.gov/cder/about/smallbiz/general_info.htm

                   IRBs and Protection of Human Subjects
                   http://www.fda.gov/cder/about/smallbiz/humans.htm

                   Clinical Investigator Inspection
                   http://www.fda.gov/cder/regulatory/investigators/default.htm

                   Regulatory and Compliance Information
                   http://www.fda.gov/cder/about/smallbiz/regs_and_compliance.htm

                   Clinical Investigator Forms

                             Disclosure of Financial Interests
                             http://forms.psc.gov/forms/FDA/FDA-3455.pdf

         FDA Forms
                   http://forms.psc.gov/forms/FDA/fda.html

                   Form 1571
                   http://forms.psc.gov/forms/FDA/1571es.pdf

                   Form 1572
                   http://forms.psc.gov/forms/FDA/FDA-1572.pdf

                   Instructions for 1571 and 1572
                   http://www.fda.gov/cder/forms/1571-1572-help.html

         FAQs on Drug Development
         http://www.fda.gov/cder/about/smallbiz/faq.htm

                   When can a trial start?
                   When is an IND number assigned?
                  Exemption

                   Exemption Request to FDA
                   Sample letter

                   Exemption Letter from FDA
                   Sample letter

                   Submission of an IND Application
                   Sample 1571
                   Sample Application