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

https://www.fda.gov/drugs/investigational-new-drug-ind-application/final-rule-investigational-new-drug-safety-reporting-requirements-human-drug-and-biological-products

FDA-Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies Guidance for Industry (DRAFT 2021)

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sponsor-responsibilities-safety-reporting-requirements-and-safety-assessment-ind-and

FDA- Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices (Draft 2021)

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigator-responsibilities-safety-reporting-investigational-drugs-and-devices

FAQs: Institutional Review Boards Frequently Asked Questions Guidance for Institutional Review Boards and Clinical Investigators

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions

FDA- “Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs

https://www.fda.gov/media/99271/download

FDA’s “E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) - Guidance for Industry

https://www.fda.gov/media/93884/download

U.S. Office for Human Research Protections (OHRP)

https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-registration/irb-registration-faq/index.html

FDA’s Information Sheet “Payment and Reimbursement to Research Subjects Guidance for Institutional Review Boards and Clinical Investigators

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/payment-and-reimbursement-research-subjects

FDA- Guidance on Informed Consent (Aug 2023)

https://www.fda.gov/media/88915/download

FDA Guidance “Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers Guidance for Institutional Review Boards, Investigators, and Sponsors” (December 2016)

https://www.fda.gov/media/116850/download

FDA- Key Information and Facilitating Understanding in Informed Consent- (March 2024)-DRAFT

https://www.fda.gov/media/176663/download

FDA-Final Rule- Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations-Effective 22 Jan 2024

https://www.federalregister.gov/documents/2023/12/21/2023-27935/institutional-review-board-waiver-or-alteration-of-informed-consent-for-minimal-risk-clinical

FDA’s Guidance Document “Adverse Event Reporting to IRBs — Improving Human Subject Protection”. Guidance for Clinical Investigators, Sponsors, and IRBs (January 2009)

https://www.fda.gov/media/72267/download

FDA guidance on E2F Development Safety Update Report (Aug 2011)

https://www.fda.gov/media/71255/download

FDA- Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry (Feb 2020)

https://www.fda.gov/media/135373/download

FDA’s Electronic Common Technical Document (eCTD)

https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd

FDA Electronics Submissions Gateway”

https://www.fda.gov/media/98901/download

FDA’s Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators - Guidance for Industry (May 2015)-DRAFT

https://www.fda.gov/files/drugs/published/Investigational-New-Drug-Applications-Prepared-and-Submitted-by-Sponsor-Investigators.pdf

FDA IND Application Procedures: Overview

https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-overview

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

https://www.fda.gov/drugs/investigational-new-drug-ind-application/information-sponsor-investigators-submitting-investigational-new-drug-applications-inds

FDA-Digital Health Technologies [DHTs] for Remote Data Acquisition in Clinical Investigations. Guidance for Industry, Investigators, and Other Stakeholders” (December 2023)

https://www.fda.gov/media/155022/download

FDA- Electronic Systems, Electronic Records and Electronic Signatures in Clinical Investigations Questions and Answers. Guidance for Industry (March 2023)- DRAFT

https://www.fda.gov/media/166215/download

FDA- Guidance “Decentralized Clinical Trials for Drugs, Biological Products, and Devices. May 2023- DRAFT

https://www.fda.gov/media/167696/download

FDA- Charging for Investigational Drugs under an IND- Questions & Answers- Feb 2024

https://www.fda.gov/media/176308/download

The U.S. International Trade Administration- US Export License

https://www.trade.gov/us-export-licenses-navigating-issues-and-resources

U.S. Department of Commerce- Export Control Classification Number (ECCN)

https://www.bis.doc.gov/index.php/licensing/commerce-control-list-classification/export-control-classification-number-eccn

U.S. National Centre for Biotechnology Information: Guidance “Domestic and International Shipping of Biospecimens”

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6777724/

ACRO- Decentralized Clinical Trials

https://www.acrohealth.org/initiatives-hub/decentralized-trials/

DTRA (Decentralized Clinical Trial Alliance)

https://www.dtra.org/

CTTI (Clinical Trials Transformation Initiative)

https://ctti-clinicaltrials.org/our-work/digital-health-trials/

FDA- A Risk-Based Approach to Monitoring of Clinical Investigations” Questions and Answers- April 2023

https://www.fda.gov/media/121479/download

FDA- Policy for Device Software Functions and Mobile Medical Applications- Sep 2022

https://www.fda.gov/media/80958/download

HIPAA- Privacy Rule

https://www.govinfo.gov/content/pkg/PLAW-104publ191/pdf/PLAW-104publ191.pdf

FDA- Cybersecurity

https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity

FDA- Guidance-Use of Electronic Health Record Data in Clinical Investigations- July 2018

https://www.fda.gov/media/97567/download

Privacy Act of 1974

https://www.ssa.gov/privacy/privacy_act_1974.html

Children’s Online Privacy Protection Act (COPPA) 1998

https://www.ftc.gov/business-guidance/resources/complying-coppa-frequently-asked-questions#A.%20General%20Questions

California Privacy Rights Act (2023)

https://oag.ca.gov/privacy/ccpa#:~:text=The%20right%20to%20delete%20personal,for%20exercising%20their%20CCPA%20rights

The White House- Executive Order on Preventing Access to Americans’ Bull Sensitive Personal Data and United States Government-Related Data by Countries of Concern (28 Feb 2024)

https://www.whitehouse.gov/briefing-room/presidential-actions/2024/02/28/executive-order-on-preventing-access-to-americans-bulk-sensitive-personal-data-and-united-states-government-related-data-by-countries-of-concern/

FDA- Guidance- Recruiting Study Subjects- Jan 1998

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recruiting-study-subjects

FDA- Guidance Ethical Considerations for Clinical Investigations of Medical Products Involving Children- Sept 2022- DRAFT

https://www.fda.gov/media/161740/download

FDA- Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations Guidance for Industry- May 2023- DRAFT

https://www.fda.gov/media/168202/download

FDA-Pediatric Drug Development: Regulatory Considerations – Complying with PREA and Qualifying for Pediatric Exclusivity Under the BPCA- May 2023- DRAFT

https://www.fda.gov/media/168201/download

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