Genome Editing Policy and Regulation

Working with Regulators

Genome Editing Capacity Building for International Regulators

At the IGI, we aim to empower regulators from low- and middle-income countries (LMICs) with technical knowledge on CRISPR genome editing.

January 2024 International Agricultural Regulatory workshop at the IGI. Learn more >

July 2022 regulatory workshop hosted at the International Rice Research Institute in collaboration with Philippines Department of Agriculture. Learn more >

Convening Regulators to Discuss Emerging Technologies

We inform regulators about advances in cutting edge CRISPR technologies to help them prepare for emerging regulatory considerations.

Genetically engineered microorganisms

Together with the U.S. Department of Agriculture (USDA) and the Phytobiomes Alliance, we organized a virtual workshop on genetically engineered microorganisms (GEMs). Public and private-sector developers shared their research projects with attendees and regulatory officials discussed regulations of GEMs-based products.

Learn more here and find the recordings from the workshop and summary findings here.

Genomic therapies

The IGI partnered with the American Society of Hematology (ASH) Research Collaborative and the U.S. Food and Drug Administration (FDA) to discuss real-world evidence for genomic therapies. Learn more >

Download the Genomic Therapies Work Group’s final report here
Download the Coordinated Registry Network Work Group’s here

Select Publications

Perspectives on Genetically Engineered Microorganisms and Their Regulation in the United States

Shams A, Fischer A, Bodnar A, and Kliegman M. ACS Synthetic Biology

(2024)

Opportunities and challenges for innovative and equitable healthcare

Ecker DJ, Aiello CD, Arron JR, Bennett CF, Bernard A, Breakefield XO, Broderick TJ, Callier SL, Canton B, Chen JS, Fishburn CS, Garrett B, Hecht SM, Janowitz T, Kliegman M, Krainer A, Louis CU, Lowe C, Sehgal A, Tozan Y, Tracey KJ, Urnov F, Wattendorf D, Williams TW, Zhao X, and Hayden MR. Nature Reviews Drug Discovery

(2024)

Towards affordable CRISPR genomic therapies: a task force convened by the Innovative Genomics Institute

Witkowsky L, Norstad M, Glynn AR, and Kliegman M. Gene Therapy

(2023)

Exploring the value of a global gene drive project registry

Taitingfong RI, Triplett C, Vásquez VN ... Marshall JM, Montague M, Morrison AC, Opesen CC, Phelan R, Piaggio A, Quemada H, Rudenko L, Sawadogo N, Smith R, Tuten H, Ullah A, Vorsino A, Windbichler N, Akbari OS, Long K, Lavery JV, Evans SW, Tountas K, Bloss CS. Nature Biotechnology

(2022)

Government Request for Input	IGI Response (click to download PDF)
FDA Draft Guidance on Manufacturing Changes and Comparability Assessment of Cellular and Gene Therapy Products (FDA-2023-D-2436)	IGI Comments – Nov 2023
FDA RFI on Individualized Cellular and Gene Therapy Product Development (FDA-2023-N-3742)	IGI Response – Nov 2023
ARPA-H RFI on Ethical, Legal, and Social Implication (ELSI) Framework	IGI Response – Oct 2023
OSTP Request for Information on the Coordinated Framework (APHIS-2022-0076)	IGI Response – Feb 2023
OSTP RFI on Biotechnology and Biomanufacturing Initiative (FR Doc. 2022-27600)	IGI Response – Jan 2023
FDA Draft Guidance on Gene Therapy Products Incorporating Genome Editing (FDA-2021-D-0398)	IGI Comments – June 2022
NCATS RFI on Early Detection and Equitable Gene Therapy Delivery for Rare Diseases (NOT-TR-21-027)	IGI Response – June 2021
USDA Proposed Rule on Movement of Certain Genetically Engineered Organisms (APHIS-2018-0034)	IGI Comments – Aug 2019
FDA Draft Guidance on Chemistry, Manufacturing, and Controls of Gene Therapy INDs (FDA-2008-D-0205)	IGI Comments – Dec 2018
FDA Draft Guidance on Long-Term Follow-Up for Gene Therapy Products (FDA-2018-D-2173)	IGI Comments – Dec 2018