US Lifecycle Management Explained: Ultimate Guide to Post-Approval Strategies and FDA Compliance Mastering US Lifecycle Management: Compliance-Driven Guide for Regulatory Affairs Professionals Introduction to US Lifecycle Management and Its Importance US lifecycle management refers to the strategic and regulatory processes involved in maintaining, updating, and extending the life of approved drugs and biologics in the United States. Managed primarily under the FDA, lifecycle management encompasses post-approval changes such as manufacturing updates, labeling modifications, new indications, and patent strategies. These activities ensure that products remain compliant, safe, effective, and commercially viable throughout their lifecycle. By 2025, lifecycle management in the US…