REGULATORY GUIDELINES

Regulations and Guidance Documents Relating to Clinical Research

Information regarding requesting and preparing for formal meetings with the FDA

https://www.fda.gov/downloads/drugs/guidances/ucm079744.pdf (PDF - 84 KB)

The most common initial meeting with the FDA is a pre-IND meeting (21 CFR 312.82).

Additional information regarding the scheduling and conduct of formal meetings

http://www.fda.gov/BiologicsBloodVaccines
/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/ucm079448.htm

Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting (dated September 1, 2015)

Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting

Information on Submitting an Investigational New Drug Application (IND) for a Biological Product:

https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/information-submitting-investigational-new-drug-application This link includes the following applicable regulations and more.

The Electronic Code of Federal Regulations
http://www.ecfr.gov/cgi-bin/text-idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl
The IND regulations contained in 21 CFR Part 312 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=312
The informed consent regulations at 21 CFR Part 50 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=50
The Institutional Review Board (IRB) regulations at 21 CFR Part 56 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=56

Guidance for Sponsors, Investigators and Institutional Review Boards: Questions and Answers on Informed Consent

, 21 CFR 50 25(C)

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf (PDF - 56 KB)

Guidance for Clinical Investigators, Sponsors and IRBs – Adverse Event Reporting to IRBs, Improving Human Subject Protection

Guidance_for_Clinical_Investigators_Sponsors_and_IRBs.pdf (PDF - 57 KB)

Guidance for IRBs, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM307779.pdf (PDF - 158 KB)

Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf (PDF - 165 KB)

Human Subject Protection – Information for Institutional Review Boards, Clinical Investigators, and Sponsors

https://www.fda.gov/science-research/guidance-documents-including-information-sheets-and-notices/information-sheet-guidance-institutional-review-boards-irbs-clinical-investigators-and-sponsors

HHS Policy for Protection of Human Subjects

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

Human Participant Protections Education for Research Teams

http://phrp.nihtraining.com/users/login.php

This free, web-based course presents information about the rights and welfare of human participants in research. The two-hour tutorial is designed for those involved in conducting research involving human participants. It satisfies the NIH human subjects training requirement for obtaining Federal Funds.

List of guidance documents related to submission of INDs

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/
ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm#FDA

FDA Regulations Relating to Good Clinical Practice and Clinical Trials

https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials

FDA regulations on the exportation of investigational new drugs, including biological products

[70 Federal Register at 70,720 (Nov. 2005)]

http://edocket.access.gpo.gov/2005/pdf/05-23120.pdf (PDF - 186 KB)

Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf (PDF - 774 KB)

Final Rule: Investigational New Drug Safety Reporting Requirement for Human Drug and Biological Products and Safety Reporting Requirement for Bioavailability and Bioequivalence Studies in Human

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved
/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm226358.htm

Regulations and Guidelines Relating to Gene Therapy Research

General information regarding the FDA regulation of Cellular and Gene Therapies

https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products

Interactions with Office of Therapeutic Products (OTP)

https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products
/interactions-office-therapeutic-products

FDA Expectations for INDs for Cellular and Gene Therapy

McFarland.pdf (PDF - 87 KB)

Gene Therapy Clinical Trials Observing Subjects for Delayed Adverse Events

https://wayback.archive-it.org/7993/20161022011729/http://www.fda.gov/downloads/BiologicsBloodVaccines
/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ucm078719.pdf

NIH Office of Science Policy

https://osp.od.nih.gov

Regulations and Guidance Documents Relating to Animal Research