General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance

The United States Pharmacopeia (USP) supports the draft guidance on using new approach methodologies (NAMs) in drug development, noting its alignment with human-centric, nonanimal testing and global scientific efforts. They advocate for a weight-of-evidence framework for evaluating novel excipients and emphasize the importance of integrating NAMs data to reduce animal testing.

Ashland, a global specialty chemicals company, supports the draft guidance on New Approach Methodologies (NAMs) to reduce reliance on animal testing. They specifically recommend that the guidance be expanded to include pharmaceutical excipients to support the development of novel, human-relevant safety data.

Michael McCue, a concerned citizen, supports the transition to non-animal methods (NAMs) in drug development and research. He urges the FDA to acknowledge the lack of scientific validation for animal testing and to adopt a 24-month roadmap for replacing animal models with modern technologies like organoids and AI.

Kelsey Kern, writing as a concerned citizen, supports the transition to non-animal methodologies (NAMs) in drug development and basic research. The commenter argues that animal testing is not scientifically validated and advocates for a 24-month roadmap to replace animal models with technologies like organoids, AI, and organ-on-chips.

The commenter, identifying as a consumer and taxpayer, supports the transition to non-animal testing methodologies. They urge the FDA to establish a clear timeline to phase out animal testing by the end of fiscal year 2027.

Michael McCue, a concerned citizen, supports the transition to non-animal methods (NAMs) in drug development and research. He urges the FDA to acknowledge the lack of scientific validation for animal testing and to adopt a 24-month roadmap for replacing animal models with modern technologies like organoids and AI.

A member of the public expresses strong support for the FDA's efforts to modernize drug development by expanding regulatory pathways for New Approach Methodologies (NAMs). The commenter argues that animal testing is ineffective and unethical, advocating for the adoption of human-relevant methods like organ-on-chip technology and computational models.

The commenter supports the FDA's efforts to expand regulatory pathways for scientifically validated alternatives to animal testing, such as human cell-based testing and organ-on-chip technology. They argue that these New Approach Methodologies (NAMs) can improve translational relevance in drug development while reducing reliance on animal studies.

An individual is expressing support for the FDA's efforts to expand regulatory pathways for New Approach Methodologies (NAMs) in drug development. They argue that technologies like organ-on-chip and computational models provide more human-relevant data than traditional animal testing and should be proactively accepted by the FDA.

A healthcare practitioner and advocate for humane education supports the FDA's efforts to expand regulatory pathways for New Approach Methodologies (NAMs). The commenter argues that human-relevant methods, such as organ-on-chip technology and computational models, should be prioritized to replace animal testing in drug development.