FDA official: ‘Complexity’ is an opportunity for speeding generic drug approvals
June 11, 2026 | Human Foods Program, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA), Department of Health and Human Services (HHS), Executive, Federal
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Dr. Lei Jung, deputy director in the Office of Research and Standards within the FDA Office of Generic Drugs, delivered the closing remarks for the two‑day "Advancing Generic Drug Development: Translating Science to Approval" workshop, emphasizing that new scientific tools can accelerate approval of complex generic products.
"Complexity is not a barrier to generic drug development, it's an opportunity for scientific innovation," Dr. Jung said, framing the workshop’s theme and the office’s work to translate regulatory science into practical guidance for industry.
Dr. Jung noted that generic medicines constitute more than 90% of prescription drugs dispensed in the United States and said they saved the U.S. health system nearly $450 billion in 2024. She stressed that those savings rely on rigorous science and robust regulatory pathways supported by the Generic Drug User Fee Amendments (GDUFA).
Speakers across the workshop presented examples of modeling and simulation that support biowaiver decisions under Biopharmaceutics Classification System (BCS) approaches, methods to address missing reference standards, and approaches to manage carryover effects in bioequivalence studies. Dr. Jung highlighted case studies discussed at the meeting, including presentations on oral semaglutide and glatiramer acetate, as examples of how regulatory science is evolving to meet increasingly sophisticated product challenges.
The deputy director described operational advances under GDUFA 3 that aim to speed guidance development for complex products. She said the Office of Generic Drugs has published more than 12,300 product‑specific guidances (PSGs) to date and that research priority areas for FY2026—determined with input from industry and the public—will drive further guidance and approvals.
Dr. Jung also announced two upcoming workshops, organized in collaboration with the Center for Research on Complex Generics (CRCG): one in October that will focus on modeling and artificial intelligence in product development and another in November addressing complex drug substances and products. Both workshops will offer free virtual participation; in‑person attendance will require a registration fee and include small‑group discussions. Attendees were directed to event materials and registration information via a QR code shown on the slide.
Throughout her remarks, Dr. Jung underscored mechanisms for early engagement between FDA and developers—pre‑submission and post‑approval meetings, subject‑matter expert triage teams and model‑integrated evidence pilot meetings—as ways to streamline development and improve submission quality.
She closed by thanking the AGDD 2025 planning committee, session leads and support staff, naming colleagues who helped plan and run the workshop, and reminding attendees that presentation slides and the meeting recording will be posted on the FDA events page.
The workshop concluded with a brief logistics note about where to find slides and recordings and encouragement to stay engaged with future FDA research and workshop activities.
"Complexity is not a barrier to generic drug development, it's an opportunity for scientific innovation," Dr. Jung said, framing the workshop’s theme and the office’s work to translate regulatory science into practical guidance for industry.
Dr. Jung noted that generic medicines constitute more than 90% of prescription drugs dispensed in the United States and said they saved the U.S. health system nearly $450 billion in 2024. She stressed that those savings rely on rigorous science and robust regulatory pathways supported by the Generic Drug User Fee Amendments (GDUFA).
Speakers across the workshop presented examples of modeling and simulation that support biowaiver decisions under Biopharmaceutics Classification System (BCS) approaches, methods to address missing reference standards, and approaches to manage carryover effects in bioequivalence studies. Dr. Jung highlighted case studies discussed at the meeting, including presentations on oral semaglutide and glatiramer acetate, as examples of how regulatory science is evolving to meet increasingly sophisticated product challenges.
The deputy director described operational advances under GDUFA 3 that aim to speed guidance development for complex products. She said the Office of Generic Drugs has published more than 12,300 product‑specific guidances (PSGs) to date and that research priority areas for FY2026—determined with input from industry and the public—will drive further guidance and approvals.
Dr. Jung also announced two upcoming workshops, organized in collaboration with the Center for Research on Complex Generics (CRCG): one in October that will focus on modeling and artificial intelligence in product development and another in November addressing complex drug substances and products. Both workshops will offer free virtual participation; in‑person attendance will require a registration fee and include small‑group discussions. Attendees were directed to event materials and registration information via a QR code shown on the slide.
Throughout her remarks, Dr. Jung underscored mechanisms for early engagement between FDA and developers—pre‑submission and post‑approval meetings, subject‑matter expert triage teams and model‑integrated evidence pilot meetings—as ways to streamline development and improve submission quality.
She closed by thanking the AGDD 2025 planning committee, session leads and support staff, naming colleagues who helped plan and run the workshop, and reminding attendees that presentation slides and the meeting recording will be posted on the FDA events page.
The workshop concluded with a brief logistics note about where to find slides and recordings and encouragement to stay engaged with future FDA research and workshop activities.
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