Introduction

The U.S. Food and Drug Administration (FDA) plays a pivotal role in ensuring the availability of safe, effective, and affordable generic medicines. Central to this mission is the Generic Drug User Fee Amendments (GDUFA) program, which provides critical funding to support the FDA’s regulatory and scientific initiatives.

The recently released Fiscal Year (FY) 2024 GDUFA Science and Research Report underscores the FDA’s commitment to overcoming scientific and regulatory challenges in generic drug development. This white paper highlights the report’s key findings, with a focus on the FDA’s strategic direction under new leadership—particularly its emphasis on complex generics, bioequivalence innovation, and regulatory modernization.

Key Scientific Priorities in the FY 2024 GDUFA Report

The report outlines eight core scientific focus areas that guide the FDA’s research agenda for FY 2024:

1. Impurities: Research is centered on identifying and mitigating harmful impurities—such as nitrosamine adducts—through advanced analytical methods and preventive strategies.
2. Complex Active Pharmaceutical Ingredients (APIs): Efforts are underway to improve the characterization of complex APIs, including oligonucleotides, and assess their immunogenicity risks.
3. Complex Dosage Forms & Formulations: The FDA is developing in vitro bioequivalence (BE) methods for long-acting injectables and polymeric formulations to predict in vivo performance and streamline approvals.
4. Complex Routes of Delivery: Research focuses on BE methodologies for locally acting drugs (e.g., nasal, inhaled, topical), aiming to reduce reliance on clinical endpoint studies.
5. Drug-Device Combination Products: The agency is evaluating how differences in device design, software, and user interfaces affect therapeutic equivalence and post-market safety.
6. Oral and Parenteral Products: Physiologically based pharmacokinetic (PBPK) modeling is being used to assess food effects and drug interactions, supporting global harmonization of BE standards.
7. Quantitative Methods & Models: The FDA is advancing model-integrated evidence (MIE) to optimize BE study design and identify failure modes, especially for locally acting products.
8. Artificial Intelligence (AI) and Machine Learning (ML): Infrastructure is being developed to integrate AI/ML tools into regulatory assessments, enhancing consistency and efficiency.

A ninth chapter highlights additional research initiatives, showcasing the FDA’s broad scientific engagement and collaboration.

Strategic Emphasis Under New FDA Leadership

The FY 2024 report reflects a proactive and forward-thinking FDA administration focused on:

• Accelerating Complex Generic Development: The FDA is prioritizing research that supports the development of complex generics—such as long-acting injectables and drug-device combinations—by creating predictive in vitro tools and refining BE methodologies.
• Modernizing Bioequivalence Assessment: Innovative BE approaches, including MIE and PBPK modeling, are being developed to reduce the need for costly and time-consuming clinical endpoint studies.
• Enhancing Drug Safety Through Impurity Control: By proactively addressing impurity formation and detection, the FDA aims to safeguard public health and prevent regulatory delays.
• Leveraging AI/ML for Regulatory Innovation: The integration of AI and ML into regulatory workflows signals a transformative shift toward data-driven, efficient decision-making.
• Fostering Global Collaboration: The FDA continues to collaborate with international research institutions and stakeholders, ensuring that regulatory science evolves in step with global best practices.

Conclusion: A New Era for Generic Drug Development

The FDA’s FY 2024 GDUFA Science and Research Report marks a significant step forward in advancing the science of generic drug development. With a strong emphasis on complex generics, innovative BE methodologies, impurity mitigation, and AI-driven regulatory tools, the FDA is paving the way for faster, safer, and more cost-effective access to high-quality generic medicines.

These initiatives not only benefit public health but also empower generic drug manufacturers with the tools and guidance needed to succeed in a competitive market.

Partner with Us: Your CRO for Regulatory Success

Navigating the complexities of generic drug development and FDA approval requires deep regulatory expertise and operational excellence. As a trusted Contract Research Organization (CRO), we offer:

• Expert management of bioequivalence (BE) studies
• Strategic guidance on Pre-ANDA meetings and Controlled Correspondences
• Preparation and submission of ANDAs and DMFs
• U.S. Agent representation for seamless FDA communication
• Timely publishing of regulatory applications

Let us help you accelerate your generic drug development program and bring high-quality, affordable medicines to market with confidence.