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Additional Resources

The Code of Federal Regulations (CFR) governing Investigative New Drug (IND) applications

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=312

 

Content and Format of an IND (21CFR312.23)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.23

 

Information on submitting a new investigational drug application

https://www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/investigationalnewdrugindordeviceexemptionideprocess/ucm094309.htm

 

Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs)

https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/ucm071098.htm

 

Clinical Investigator Information

https://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/InvestigationalNewDrugINDorDeviceExemptionIDEProcess/ucm094294.htm

 

Form 1571

https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083533.pdf

 

Form 1572 (Statement of Investigator)

https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074728.pdf

 

Form 3674 (Certification of trial registration on ClinicalTrials.gov)

https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM048364.pdf

 

Final Rule for Clinical Trials Registration and Results Information Submission

https://prsinfo.clinicaltrials.gov/

 

Investigator’s Checklist for IND Application Submission

https://www.fda.gov/downloads/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/ucm368873.pdf

 

NIH Recombinant DNA Advisory Committee

https://osp.od.nih.gov/biotechnology/recombinant-dna-advisory-committee/

 

The NIH Review Process for Human Gene Transfer Trials

https://osp.od.nih.gov/biotechnology/faq-onthe-nih-review-process-for-human-gene-transfer-trials/

 

American Society of Gene and Cell Therapy

https://www.asgct.org/

 

ICH Guideline for Good Clinical Practice E6(R2)

http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4_2016_1109.pdf