On August 7, 2025, the U.S. Food and Drug Administration (FDA) announced FDA PreCheck, a new two-phase framework aimed at bolstering the domestic pharmaceutical supply chain by streamlining the regulatory process […]
The Trump administration’s Executive Order entitled, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” notes a desire to bolster supply chains, enhance national security, and ensure compliance with evolving regulatory frameworks. Nevertheless, the decision to relocate manufacturing operations for U.S. Food and Drug Administration (FDA)-approved drugs is fraught with regulatory obligations – including those administered by the FDA – and strategic considerations that must be thoroughly analyzed.
A U.S. Supreme Court ruling which overturned the famous Chevron ruling by deciding courts should not defer to an agency’s interpretation of the law is likely to usher in a new era of both opportunity and risk for life sciences companies seeking to review FDA decisions. Michael Varrone explains.