FDA Actions to Support and Strengthen Domestic Drug Manufacturing

The FDA is taking decisive steps to help strengthen U.S. pharmaceutical manufacturing, improve supply chain resilience, and ensure Americans have reliable access to safe, effective, high-quality medicines. The initiatives and actions below reflect FDA's commitment to engaging with manufacturers earlier, modernizing oversight tools, streamlining regulatory processes, and helping incentivize domestic investment — all while upholding FDA's rigorous standards.

PreCheck Pilot Program
FDA's voluntary PreCheck Pilot Program is designed to strengthen the domestic pharmaceutical supply chain by helping companies building new drug manufacturing facilities in the United States engage with the FDA earlier in the development process. The program has two phases: an early Facility Readiness Phase, where manufacturers receive technical and regulatory feedback before operations begin, and an Application Submission Phase, which includes enhanced FDA engagement to resolve manufacturing questions and expedite review of facility information and inspections. By identifying potential issues earlier, the program aims to reduce delays, improve regulatory predictability, and accelerate the availability of U.S.-manufactured medicines. On June 29, 2026, FDA announced seven participating companies: Eli Lilly, Regeneron, Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics, and Kyowa Kirin.

Operation TrialBlazer
Operation TrialBlazer is an HHS and FDA initiative to modernize and accelerate clinical drug development by reducing unnecessary regulatory burden while maintaining FDA's standards for safety and effectiveness. The initiative includes an expedited Phase 1 IND pilot; streamlined Chemistry, Manufacturing, and Controls (CMC) requirements for early development; greater use of computational tools to support dose selection; more flexible approaches to late-stage clinical trials; and new resources to help sponsors navigate the regulatory process. Together, these efforts are intended to shorten development timelines, reduce unnecessary costs, and make the United States a more attractive location for biomedical research, clinical development, and pharmaceutical innovation.

ANDA Prioritization Pilot Program
The ANDA Prioritization Pilot Program provides an opportunity for priority review for certain generic drug applications that involve domestic pharmaceutical manufacturing. To qualify, applicants generally must conduct bioequivalence testing in the United States (or qualify for a waiver), manufacture the finished dosage form domestically, and source active pharmaceutical ingredients (APIs) exclusively from U.S.-based suppliers. By prioritizing these applications, FDA aims to help encourage investment in U.S. manufacturing, strengthen the domestic drug supply chain, reduce dependence on foreign production, and improve patient access to lower-cost generic medicines. Applicants may request participation through FDA's existing ANDA prioritization procedures.

Commissioner's National Priority Voucher (CNPV) Pilot Program
The Commissioner's National Priority Voucher (CNPV) Pilot Program provides an accelerated review pathway for selected drugs and biologics that advance critical U.S. public health and national priorities. Eligible products may include therapies that address public health emergencies, unmet medical needs, transformative scientific advances, domestic manufacturing and supply chain resilience, or improved affordability. The program uses intensive multidisciplinary review teams, rolling submissions, and enhanced communication with sponsors to significantly shorten review timelines while maintaining the same statutory standards for safety, effectiveness, and product quality. Unlike traditional Priority Review Vouchers, CNPVs are non-transferable and cannot be bought or sold.

Pre-Approval Inspection and Pre-License Inspection
FDA's Pre-Approval Inspection (PAI) and Pre-License Inspection (PLI) compliance programs provide the framework for evaluating whether manufacturing facilities are prepared to produce drugs and biologics that meet requirements for marketing approval. Through these inspections, FDA investigators assess manufacturing operations, quality systems, data integrity, process controls, and whether the facility's practices conform to the information submitted in the marketing application. The programs help ensure that manufacturers can consistently produce safe, effective, high-quality products that meet current good manufacturing practice (CGMP) requirements. When appropriate, FDA may also use alternative assessment tools, such as Remote Regulatory Assessments (RRAs) e.g., or remote interactive evaluations, to support regulatory decision-making while maintaining oversight of manufacturing quality and compliance. FDA recently published the new PLI compliance program (7346.832M) on April 14, 2026, and the revised PAI compliance program (7346.832) on June 29, 2026 which describe FDA’s risk-based approaches to these inspections.

Quality Management Maturity (QMM) Program
FDA is also developing the Quality Management Maturity (QMM) Program, which aims to encourage drug manufacturers to implement quality management practices that go beyond baseline current good manufacturing practice (CGMP) requirements. Adopting mature quality management practices supports a more reliable drug supply chain by reducing the occurrence of quality-related failures and improving the ability of establishments to maintain performance during expected and unexpected supply chain disruptions. This program encourages pharmaceutical manufacturers to adopt mature quality management practices for improving efficiency, reducing costs, and driving continuous improvement.

This work is an ongoing process: The FDA will continue to collaborate, engage stakeholders, and innovate to ensure our guidance remains relevant, science-based, and responsive to the realities of the pharmaceutical manufacturing landscape.

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