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          Advancing Generic Drug Development: Translating Science to Approval 2023 - 09/13/2023News & Events for Human Drugs Conference
    Event Title
              Advancing Generic Drug Development: Translating Science to Approval 2023


                  September 13 - 14, 2023

  

    
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      Meeting InformationDate:
          
  


     
                                                       
       

September 13 - 14, 2023   

 
 
        
                
                                      Day1: 
              Wed, Sep 13 9:00 AM
 - 5:00 PM
 ET
            
                      Day2: 
              Thu, Sep 14 9:00 AM
 - 5:00 PM
 ET

 

  

Topics & Presentations Day 1
			SpeakersAdvancing Generic Drug Development: Translating Science to Approval 2023 – Day 1 – Part 1Keynote
			**Robert M. Calif, MD, MACC***Commissioner of Food and Drugs*
			U.S. Food and Drug Administration (FDA)General Guidances Related to Characterization-Based Bioequivalence Approaches for Topical Products – Part I.pdf
			**Priyanka Ghosh, PhD***Lead Pharmacologist*
			Division of Therapeutic Performance I (DTP I)
			Office of Research and Standards (ORS)
			Office of Generic Drugs (OGD)
			Center for drug Evaluation and Research (CDER)General Guidances Related to Characterization-Based Bioequivalence Approaches for Topical Products – Part II.pdf
			**Hiren Patel, PhD***Senior Staff Fellow*
			Division of Bioequivalence II (DB II)
			Office of Bioequivalence (OB)
			OGD | CDERAn Overview of the Current Product-Specific Guidances for Topical Products.pdf
			**Megan Kelchen, PhD***Senior Pharmacologist*
			DTP I | ORS | OGD | CDERHow Research Supports Product-Specific Guidances for Topical Products.pdf
			**Ahmed Zidan, PhD***Senior Staff Fellow*
			Division of Product Quality Research (DPQR)
			Office of Testing and Research (OTR)
			Office of Pharmaceutical Quality (OPQ) | CDERAdvancing Generic Drug Development: Translating Science to Approval 2023 – Day 1 – Part 2.pdfOverview and Changes to Guidance for Industry: Topical Dermatology Corticosteroids In Vivo Bioequivalence.pdf
			**Ke Ren, PhD***Deputy Division Director*
			Division of Bioequivalence III (DB III)
			OB | OGD | CDERANDA Challenges Related to Vasoconstrictor Studies.pdf
			**Kairui (Kevin) Feng, PhD***Senior Chemical Engineer*
			Division of Quantitative Methods and Modeling (DQMM)
			ORS | OGD | CDERSession 1: Q&A Discussion Panel
			**Priyanka Ghosh, Hiren Patel, PhD, Megan Kelchen, Ahmed Zidan, Ke Ren, Kairui (Kevin) Feng**,

			and

			**Markham C. Luke, MD, PhD***Division Director*
			DTP I | ORS | OGD | CDER

			**Sam Raney, PhD***Associate Director for Science*
			ORS | OGD | CDER

			**Pahala Simamora, PhD***Division Director*
			Division of Liquid-Based Products II (DLBP II)
			Office of Lifecycle Drug Products (OLDP)
			OPQ | CDER | FDA

			**Rong Wang, PharmD, PhD***Associate Director*
			Division of Bioequivalence I (DB I)
			OB | OGD | CDERAdvancing Generic Drug Development: Translating Science to Approval 2023 – Day 1 – Part 3.pdfComplex Nasal Suspension PSG: Utilization of Newly Recommended In Vitro Only Bioequivalence Option.pdf
			**Susan Boc, PhD***Pharmacokineticist*
			DTP I | ORS | OGD | CDERComplex Nasal Suspension: Utilization of In Silico PK Studies to Support Development and Approval.pdf
			**Ross Walenga, PhD***Senior Chemical Engineer*
			DQMM | ORS | OGD | CDERLoxapine Inhalation Powder: OTR Research Conducted to Inform the PSG Recommendations.pdf
			**Nathan Reed, PhD***Chemist*
			Division of Complex Drug Analysis, Branch 2 (DCDA B2)
			Office of Testing and Research (OTR)
			OPQ | CDER | FDA

			**Elizabeth Bielski, PhD***Senior Pharmacologist*
			DTP I | ORS | OGD | CDERSession 2: Q&A Discussion Panel
			**Susan Boc, Ross Walenga, Nathan Reed, Elizabeth Bielski, Ahmed Zidan**,

			and

			**Vipra Kundoor, PhD***Pharmacologist*
			DB I | OB | OGD | CDER

			**Mai Tu, PhD***Chemist*
			Liquid-Based Branch IV (LBB4)
			DLBP II | OLDP | OPQ | CDER | FDAAdvancing Generic Drug Development: Translating Science to Approval 2023 – Day 1 – Part 4.pdfIn Vitro Approaches for Injectable Suspension Products: Medroxyprogesterone Acetate & Triamcinolone Acetate.pdf
			**Qiangnan Zhang, PhD***Staff Fellow*
			DTP I | ORS | OGD | CDERRisk-based PSG Recommendations for Comparative Immunogenicity and Impurity Profile Assessment.pdf
			**Eric Pang, PhD***Senior Chemist*
			DTP I | ORS | OGD | CDERSession 3: Q&A Discussion Panel
			**Qiangnan Zhang, Eric Pang**,

			and

			**Dapeng Cui, PhD***Lead Pharmacologist*
			DB I | OB | OGD | CDER

			**Cameron Smith, PhD***Branch Chief*
			Division of Liquid-Based Products I (DLBP I)
			OLDP | OPQ | CDERCyclosporine & Difluprednate Ophthalmic Emulsions - Part 1.pdfCyclosporine & Difluprednate Ophthalmic Emulsions - Part 2.pdf
			**Qiuxi Fan, PhD***Pharmaceutical Scientist*
			DLBP II | OLDP | OPQ | CDER

			**Yoriko Harigaya, PharmD***Senior Staff Fellow*
			DB II | OB | OGD | CDERAmphotericin B Liposome: Changes Identified.pdf
			**Bin Qin, PhD***Senior Chemist*
			DTP I | ORS | OGD | CDERPhytonadione – Self-Assembled System & Thermodynamics Systems.pdf
			**William Smith, PhD***Research Scientist*
			Division of Product Quality Research (DPQR)
			OTR | OPQ | CDERSession 4: Q&A Discussion Panel
			**Qiuxi Fan, Yoriko Harigaya, Bin Qin, William Smith**,

			and

			**John Jiang, PhD***Chemist*
			DLBP II | OLDP | OPQ | CDER

			**Hee Sun Chung, PhD***Lead Pharmacologist*
			DB I | OB | OGD | CDER

			**Khondoker Alam, PhD***Senior Pharmacologist*
			DQMM | ORS | OGD | CDER

			**Xiaoming Xu, PhD***Supervisory Chemist*
			DPQR | OTR | OPQ | CDERDay One Closing Remarks
			**Lei Zhang, PhD***Deputy Director*
			ORS | OGD | CDER

Topics & Presentations Day 2
			SpeakersAdvancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 1Innovative Technology: Particle Image Velocimetry (PIV) and High-Speed Imaging to Support Approval of Generic Orally Inhaled Drug Products.pdf
			**Steven Chopski, PhD***Staff Fellow*
			DQMM | ORS | OGD | CDERFirst Generic Drug Approval: Budesonide & Formoterol Fumarate Dihydrate Inhalation Aerosol (RLD: Symbicort): A Bioequivalence Perspective.pdf
			**Zhen Xu, PhD***Staff Fellow*
			DB III | OB | OGD | CDERFirst Generic Drug Approval: Budesonide & Formoterol Fumarate Dihydrate Inhalation Aerosol (RLD: Symbicort): A Quality Perspective.pdf
			**Fang Yuan, PhD***Senior Chemist*
			Immediate Office (IO)
			OLDP | OPQ | CDERPost-Approval Impact of Generic Fluticasone Propionate & Salmeterol Inhalation Powder (RLD: Advair Diskus).pdf
			**Andrew Clerman, MD, PhD***Senior Physician*
			DTP I | ORS | OGD | CDERSession 5: Q&A Discussion Panel
			**Steven Chopski, Zhen Xu, Fang Yuan, Andrew Clerman**,

			and

			**Srinivas Behara, PhD***Chemist*
			Division of Immediate and Modified Release Products III (DIMRP III)
			OLDP | OPQ | CDER

			**Tian Ma, PhD***Senior Staff Fellow*
			DB I | OB | OGD | CDER

			**Elizabeth Bielski, PhD***Senior Pharmacologist*
			DTP I | ORS | OGD | CDERAdvancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 2Bioequivalence for Oral Locally Acting Gastrointestinal Drug Products.pdf
			**Wei-Jhe Sun, PhD***Senior Staff Fellow*
			DTP II | ORS | OGD | CDERQ1/Q2 Recommendation (Sucralfate).pdf
			**Manar Al-Ghabeish, PhD***Staff Fellow*
			DTP II | ORS | OGD | CDERNon-Q2 Sucralfate Suspension Approval.pdf
			**Suman Dandamudi, PhD***Senior Pharmacologist*
			DB III | OB | OGD | CDERSession 6 Q&A Discussion Panel
			**Wei-Jhe Sun, Manar Al-Ghabeish, Suman Dandamudi**,

			and

			**Alicia Hoover, PhD***Supervisory Chemist*
			Division of Pharmaceutical Analysis (DPA)
			OTR | OPQ | CDER

			**Fang Wu, PhD***Senior Pharmacologist*
			DQMM | ORS | OGD | CDER

			**Hongfei Zhou, PhD***Senior Pharmacologist*
			DB III | OB | OGD | CDERAdvancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 3GDUFA Research Program: Research Priorities to Support Generic Drug Development.pdf
			**Sam Raney, PhD***Associate Director for Science*
			ORS | OGD | CDERIdentify Research Needs and PSG Development for Complex Products.pdf
			**Xiaoming Xu, PhD***Division Director*
			DPQR | OTR | OPQ | CDEREnhance Communication in Using Modeling Approaches in ANDAs.pdf
			**Liang Zhao, PhD***Division Director*
			DQMM | ORS | OGD | CDERSession 7: Q&A Discussion Panel
			**Sam Raney, Xiaoming Xu, Liang Zhao**,

			and

			**Darby Kozak, PhD***Deputy Division Director*
			DTP I | ORS | OGD | CDER

			**Robert Lionberger, PhD***Director*
			ORS | OGD | CDER

			**Zhen Zhang, PhD***Master Pharmacologist*
			DB I | OB | OGD | CDERAdvancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 4The Generic Drug Cluster Program and the Path to Global Harmonization.pdf
			**Sarah Ibrahim, PhD***Associate Director for Global Affairs*
			OGD | CDERSupporting the First Harmonized Bioequivalence Guideline under ICH -Considerations for Future Implementation.pdf
			**Nilufer Tampal, PhD***Associate Director for Scientific Quality*
			OB | OGD | CDERFDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Drug Products.pdf
			**Lei Zhang, PhD***Deputy Director*
			ORS | OGD | CDERData Reliability – Inspection, Global Collaboration.pdf
			**Brian Folian, JD, MS***Deputy Director*
			Office of Study Integrity and Surveillance (OSIS)
			Office of Translational Sciences (OTS) | CDERSession 8: Q&A Discussion Panel
			**Nilufer Tampal, Lei Zhang, Sarah Ibrahim, Brian Folian**,

			and

			**Wenlei Jiang, PhD***Senior Advisor for Innovation and Strategic Outreach*
			ORS | OGD | CDER

			**Xiaojian Jiang, PhD***Deputy Division Director*
			DB II | OB | OGD | CDER

			**Myong-Jin Kim, PharmD***Division Director*
			DTP II | ORS | OGD | CDERDay Two Closing Remarks
			**Robert Lionberger, PhD***Director*
			ORS | OGD | CDER

Agenda

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS EVENT

The purpose of this public workshop is to communicate how FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program outcomes guide and facilitate generic drug development, regulatory assessment, and approval. This workshop will focus on common issues seen in abbreviated new drug applications (ANDAs), GDUFA III updates, GDUFA science and research on complex products and scientific issues to product-specific guidance development, pre-ANDA, and ANDA meeting discussions, and examine various areas of innovative science and cutting-edge methodologies behind generic drug development.

INTENDED AUDIENCE

Scientists, researchers, current and prospective generic drug applicants
	Regulatory affairs professionals who work on or have an interest in the development of generic drugs, including complex generic products.TOPICS COVERED

Generic product approval and supporting research, featuring:

Products with complex active pharmaceutical ingredients (APIs)
	Complex injectable product
	Topical drug products
	Ophthalmic emulsion products
	Orally inhaled drug products
	Noteworthy guidance development and updates
	New process/research/assessment tools to support generic product development and post-market surveillance
	Global collaboration to support efficient generic product development and regulatory assessmentLEARNING OBJECTIVES

Comprehend new developments in science, guidance, and regulatory assessment experience for generic drug products
	Keep up to date on GDUFA III enhancements and changes
	Understand FDA’s perspectives, research, and regulatory assessment relating to generic drug development
	Apply various mechanisms and methodologies that drug developers can use to facilitate generic drug developmentFDA RESOURCES

GDUFA Science and Research
	Generic Drug Development
	GDUFA III Reauthorization
	Pre_ANDA Program
	Product-Specific Guidances for Generic Drug Development
	Guidances Related to Generic Drugs

                                                                                  Content current as of:
      10/27/2023
         
                   
Regulated Product(s)
		 DrugsMore Meetings,
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