Comment from Pearl BioSystem SAS
AnonymousSupportBusiness
Summary: Pearl BioSystem SAS, a French biotechnology company, supports the FDA's draft guidance on New Approach Methodologies (NAMs) and proposes specific improvements to include matrix-free 3D cell culture systems. They advocate for clarifying pre-IND screening contexts, recognizing compound bioavailability as a validation criterion, establishing a staged validation pathway for SMEs, and providing example Contexts of Use for 3D spheroid platforms.
Pearl BioSystem SAS respectfully submits the attached formal public comment regarding the FDA draft guidance “General Considerations for the Use of New Approach Methodologies in Drug Development” (Docket No. FDA-2025-D-6131).
The attached document presents recommendations concerning matrix-free 3D cell culture systems, proposed Contexts of Use (COU), staged validation pathways for SMEs, and the deployment of the in perlo platform as a human-relevant New Approach Methodology (NAM).
Submitted by:
Pearl BioSystem SAS
Strasbourg, France
www.pearlbiosystem.com