FDA's America First Agenda: Reshaping Global Pharma Manufacturing
Day 1 Manufacturing 5.0 Stage
06/10/2026 12:25 - 12:50pm
Contributors
Gil Roth : President - PBOA - Pharma & Biopharma Outsourcing Association
An in-depth examination of how FDA's user fee negotiations, "America First" proposals, and Pre-Check Program are incentivising domestic investment while creating nuanced barriers for CMOs and international manufacturers navigating US market access. These policy shifts extend through 2031-2032 and are fundamentally altering global pharmaceutical investment patterns and manufacturing location decisions.