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
Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting (dated September 1, 2015)
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 Regulationshttp://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
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
FDA Regulations Relating to 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
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)
FDA Expectations for INDs for Cellular and Gene Therapy
Gene Therapy Clinical Trials Observing Subjects for Delayed Adverse Events
NIH Office of Science Policy
Regulations and Guidance Documents Relating to Animal Research
Policies and Regulations regarding Laboratory Animal Welfare
- https://olaw.nih.gov/
- https://olaw.nih.gov/policies-laws/phs-policy.htm
- https://www.nal.usda.gov/awic
Information Resources for Institutional Animal Care and Use Committee (IACUC)
TRENDING NEWS
REGULATORY UPDATES
- INTERACT Meetings (formerly pre-pre-IND meetings)
- FDA INTERACT Announcement 2018
- CBER INTERACT Meeting Process Overview (PowerPoint | Word)
- Revised NIH Guidelines (April 2019)
RESOURCE CENTER
- GTRP Request for Service Application (RSA)
- NHLBI Home
- Future Directions and Resource Needs for NHLBI Gene Therapy Research
- Funding Resources – NIH and Other Programs
- GTRP FAQs
- Regulatory Resources
- Training Resources - NIH and FDA
- Publications and Presentations by GTRP Investigators
- American Society of Gene and Cell Therapy (ASGCT) Homepage
- Archived GTRP Newsletters