Strengthening U.S.-Based Generic Drug Development

On October 3, 2025, the U.S. Food and Drug Administration (FDA) announced the abbreviated new drug applications (ANDA) Prioritization Pilot Program, a strategic initiative designed to encourage investment in domestic drug development, testing, and manufacturing. The pilot supports the FDA’s ongoing effort to strengthen the U.S. pharmaceutical supply chain and promote faster access to affordable generic medicines.🔗 Read the official FDA announcement

What the Program Offers

Under this pilot, ANDAs that meet certain U.S.-based criteria can qualify for priority review – allowing faster regulatory assessment and potentially earlier market entry for approved products.

To be eligible, applicants must demonstrate that:

1. Bioequivalence studies are conducted in the United States (or qualify for a waiver of BE testing).
2. The finished dosage form is manufactured in the U.S.
3. The active pharmaceutical ingredient (API) is sourced exclusively from a domestic supplier.

By rewarding companies that invest in local infrastructure, the FDA aims to enhance manufacturing resilience and encourage more research activity within the United States.

Why This Matters

The pilot represents a meaningful step in reducing dependency on overseas manufacturing and ensuring that critical medicines can be produced and tested within the country. For Sponsors, meeting the eligibility criteria can be translated to:

• Shorter FDA review timelines
• Earlier product launches
• Strengthened compliance positioning
• Contribution to U.S. supply chain security

Novum’s Role in Supporting Sponsors

Novum Pharmaceutical Research Services offers extensive capabilities to help Sponsors meet the requirements of the FDA’s ANDA Prioritization Pilot.

With fully equipped clinical research facility in Las Vegas, Novum provides:

• Proven experience in bioequivalence and early-phase studies
• Experienced clinical, medical, and regulatory teams ensuring quality data and efficient execution
• Transparent operations aligned with Sponsor timelines for faster ANDA readiness
• State-of-the-art clinical facility in Las Vegas with 191 beds, including 15 Phase-I beds
• Established compliance with FDA, EMA, ICH-GCP standards and scientific expertise ensuring high-quality ANDA submissions

By partnering with Novum, Sponsors can conduct their BE studies within the United States and position their ANDA applications for priority FDA review, achieving faster time-to-market while contributing to the FDA’s broader vision of strengthening U.S.-based drug research and manufacturing.

Faster ANDA Review = Faster Market Entry.

Partner with Novum to advance your U.S.-based generic development program with confidence and compliance. Connect with our team at