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# BIO Urges Broader Guidance on Monoclonal Antibody Safety Testing
- URL: https://www.fdaweb.com/bio-urges-broader-guidance-on-monoclonal-antibody-safety-testing/
- Published: 2026-02-09T12:00:00.000Z
- Updated: 2026-09-14T15:32:48.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160632

The Biotechnology Innovation Organization (BIO) has submitted [detailed comments](https://www.regulations.gov/comment/FDA-2025-D-4634-0005?ref=fdaweb.com) to FDA recommending broader application of its draft guidance on “Monoclonal Antibodies (mAbs): Streamlined Nonclinical Safety Studies.” The comments highlight ways the agency could reduce animal testing while maintaining rigorous safety standards.

BIO praised FDA for emphasizing the 3R principles — replace, reduce, refine animal use — and the Weight-of-Evidence (WoE) approach in its draft guidance. However, the group urged FDA to expand the scope beyond monospecific antibodies for non-oncology indications to include multispecific and conjugated antibodies across all therapeutic areas, including oncology.

The comments call for clarification on how sponsors can leverage prior knowledge from other mAbs without violating intellectual property or requiring a right of reference, and how to apply the WoE approach in planning nonclinical safety assessments. BIO also suggested the FDA provide clearer definitions of study durations, guidance on pediatric and pregnancy indications, and specific criteria for when longer toxicology studies might be needed.

BIO emphasized that global harmonization of safety testing requirements is critical to avoid redundant studies and to encourage evidence-based approaches across regulatory regions. The organization recommended the FDA formally recognize “New Approach Methodologies” (NAMs) and ensure the draft guidance reflects these progressive, science-driven strategies.

By clarifying these points, BIO argued, FDA could give sponsors greater confidence in reducing unnecessary nonclinical studies, while ensuring patient safety and accelerating the development of innovative monoclonal antibody therapies.

Pharmaceutical Research and Manufacturers of America also [submitted comments](https://www.regulations.gov/comment/FDA-2025-D-4634-0013?ref=fdaweb.com) that echoed points raised in BIO’s submission.