Human‑First Science. NAMs- driven Innovation.

Replacing and Reducing Animal Testing at CDER

CDER's primary focus is ensuring the safety and efficacy of human drugs. It has become increasingly clear that new approach methodologies (NAMs)-when combined with knowledge of the pathway, results of pharmacology studies, and other relevant data-may offer ways to achieve this goal more effectively and efficiently than traditional animal testing. Furthermore, NAMs support CDER's long-standing interest and investment in Implementing the 3Rs (Replacement, Reduction, and Refinement) of animal testing in drug development, aligning with both FDA's priorities and those of the public. By embracing NAMs and other methods of replacing and reducing animal testing, CDER aims to enhance its ability to protect public health, improve the drug development process, and respond to evolving scientific advancements in the field of drug evaluation and safety assessment.

Drug Development Contexts for Streamlined Nonclinical Programs

This table contains an inventory of drug development contexts for which CDER is open to a streamlined nonclinical program. This includes but is not limited to reduced sample size, reduced number of species tested, and NAMs use. This table excludes 505(b)(2), generic, and biosimilar pathways as well as studies related to impurities and excipients. This table provides general information; sponsors should consult guidance documents and appropriate FDA review divisions for more information. The FDA regularly revises existing guidance documents and publishes new guidance documents. This table will be updated as new information becomes available.