EO 14293
Regulatory Relief To Promote Domestic Production of Critical Medicines
HealthcareNational SecurityEconomy & Trade
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Summary
This executive order directs the Food and Drug Administration to streamline regulatory requirements for domestic pharmaceutical manufacturing to reduce construction timelines and eliminate barriers to producing medicines and critical inputs in the United States. The order aims to accelerate FDA review processes, modernize inspection protocols, and increase oversight of foreign manufacturing facilities.
Key Points
- 1FDA must review and eliminate duplicative or unnecessary regulations within 180 days that apply to domestic pharmaceutical manufacturing, including inspections and approval of new manufacturing capacity and emerging technologies
- 2The order seeks to improve the risk-based inspection approach for domestic facilities to make inspections more prompt, efficient, and limited to necessary compliance checks under federal law
- 3FDA must enhance routine inspections of foreign manufacturing facilities and develop clearer guidance on requirements for moving production from foreign to domestic facilities
- 4The order cites concerns that building new pharmaceutical manufacturing capacity currently takes 5-10 years and that FDA inspections of domestic manufacturers are more frequent than those at international facilities
This summary is for informational purposes only. It may not capture all nuances of the executive order. Always refer to the official text for authoritative information.
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