Charles River’s Response to FDA’s Announcement

Charles River supports the FDA's recent focus on alternatives, which aligns with our vision and long-standing commitment to ethical research practices. We view this as a long-term opportunity for our business and intend to be a leader in the transition. For decades, Charles River has invested in the replacement, reduction and refinement (3Rs) of ethical animal use for biomedical research. We have supported the FDA’s efforts to advance the validation and adoption of New Approach Methods (NAMs), including through the launch of our Alternative Methods Advancement Project (AMAP), an initiative dedicated to developing alternatives to reduce animal testing.

As an industry leader, Charles River is committed to:

• Continuing to invest in innovative non-animal platforms;
• Advancing the integration of NAMs into hybrid study designs, and;
• Assisting biopharmaceutical clients in validating and advancing the use of NAMs.

The transition to NAMs is an evolutionary rather than revolutionary process. In the coming years, we look forward to continuing to work collaboratively with regulatory agencies, including the FDA, the biopharmaceutical industry, and other stakeholders. Together, we aim to develop, validate, and implement an efficient process for our clients’ regulatory submissions that supports the use of non-animal technologies and NAMs. As we always have, Charles River will remain committed to following the best and latest science to ensure patient safety.