CRISPR, animals, and FDA oversight: Building a path to success

Area of Science:

• Animal biotechnology
• Genome editing technologies
• CRISPR applications

Background:

• Innovative biotechnologies, including CRISPR, show promise for public health solutions.
• These solutions include disease transmission control, sustainable food, and human therapeutics via animal models.
• The Food and Drug Administration (FDA) acknowledges the need for these advancements.

Purpose of the Study:

• To describe the current scientific landscape of intentional genomic alterations in animals.
• To outline scientific limitations and considerations for researchers and developers.
• To present the FDA's risk-based regulatory approach for animal biotechnology.

Main Methods:

• Review of current scientific advancements in animal genome editing.
• Analysis of scientific limitations and challenges.
• Description of the FDA's risk-based regulatory framework.

Main Results:

• Technological progress in genome editing presents opportunities for public health and therapeutics.
• Scientific limitations and considerations must be addressed by developers.
• The FDA employs a balanced, risk-based approach to efficiently bring products to market.

Conclusions:

• Collaboration and science- and risk-based oversight are crucial for advancing animal biotechnology.
• The FDA is committed to improving regulatory processes through stakeholder input.
• Ensuring safety and efficacy is paramount for innovative animal biotechnology products.