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Table of Contents (Each link below will open a 11 MB PDF) Introduction Joint Directors' Message Chapter 1: Impurities Chapter 2: Complex APIs Chapter 3: Complex Dosage Forms & Formulations Chapter 4: Complex Routes of Delivery Chapter 5: Drug-Device Combination Products Chapter 6: Oral and Parenteral Products Chapter 7: Quantitative Methods & Models Chapter 8: Data Analytics & Artificial Intelligence Chapter 9: Other Generic Product Science & Research Acknowledgments Appendix: GDUFA Science and Research Outcomes for Fiscal Year 2025 Joint Directors Message The Generic Drug User Fee Amendments (GDUFA) science and research program facilitates patient access to high-quality, safe, and effective generic drugs

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