America Must Address Early Clinical Development

America Must Address Early Clinical Development https://www.fda.gov/news-events/fda-voices/america-must-address-early-clinical-development?utm_medium=email&utm_source=govdelivery America Must Address Early Clinical Development The Problem: America is at Risk of Being Left Behind America is losing ground on clinical trials. Phase 1 trials that may take up to two years to complete here in the United States are completed in nine months in China, threatening America’s leadership in scientific innovation. To combat this, President Trump and Secretary Kennedy have directed the U. S. Food and Drug Administration to use every tool at its disposal to reverse this trend. The consequences are broad. Patients lose access to investigational therapies and may have to travel abroad to enroll. The FDA’s ability to shape science and oversee safety diminishes when trials move overseas. For investors, slower and less predictable U.S. regulatory timelines push early-stage capital, along with jobs and intellectual property, to other countries. Why the Current Pre-IND Process Isn't Optimal Outdated Process, Growing Demand: The pre-IND process was built for a simpler era. Drug development has grown more complex, diverse, and voluminous, particularly with novel modalities like cell and gene therapies, and the current system cannot meet that demand at scale.