draft

Implement a gap analysis for 505(b)(2) applications to identify safety data needs and adjust safety monitoring systems as necessary to accommodate new product characteristics.

PV operations and quality teams must review and implement the updated guidance in their processes, ensuring compliance with the revised monitoring and reporting requirements.

Stakeholders must prepare for discussions about the integration of QSP methods in investigational new drug (IND) submissions, including a review of IND data packages to align with the new recommendations.

Stakeholders involved in biosimilar product development must review the draft guidance, focus on comparative safety assessments, and submit relevant comments by the deadline of October 2, 2026.