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Event Title
Generic Drugs Forum (GDF) 2025
April 9 - 10, 2025


Date:
April 9 - 10, 2025
Day1:
Wed, Apr 9
Day2:
Thu, Apr 10


Day 1 Topics & Presentations

Speakers

Generic Drugs Forum – Day One - Opening and Session 1

Office of Generic Drugs (OGD) Keynote

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Darby Kozak, PhD
Deputy Director
Office of Generic Drugs (OGD)
CDER

Office of Pharmaceutical Quality (OPQ) Keynote - Recording

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Geoffrey Wu, PhD
Commander | United States Public Health Service (USPHS)
Acting Director
Office of Product Quality Assessment I (OPQA I)
Office of Pharmaceutical Quality (OPQ) | CDER

Abbreviated New Drug Applications (ANDA) Missed Goal Dates: An Update on Metrics and Internal Communications

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Edward (Ted) Sherwood
Director
Office of Regulatory Operations (ORO)
OGD | CDER

Request For Reconsideration: Process Overview and Best Practices for FDA Evaluation 

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Joe Shin, PharmD
Lead Regulatory Health Project Manager
DPM | ORO | OGD | CDER

Request for Reconsideration Under Generic Drug User Fee Amendment (GDUFA) III – Overview and Experience from Bioequivalence Perspectives 

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Yi Zhang, PhD
Associate Director
Division of Bioequivalence III (DBIII)
Office of Bioequivalence (OB) | OGD | CDER

Questions & Panel Discussion

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Ted Sherwood, Scott Vehovic, Joe Shin and Yi Zhang

Generic Drugs Forum – Day One - Session 2

Best Practices for Generic Drug Labeling

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Churg (Stella) Chan, PharmD, BCPS
Pharmacist
Division of Labeling Review (DLR)
ORO | OGD | CDER

Project Managing Drug Assessors Under GDUFA III Regulations 

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Nuri Tawwab, PharmD, MPH
Lieutenant Commander | USPHS
Stakeholder Engagement Team
Division of Prevention Communication and Public Engagement (DPCPE)
Center for Substance Abuse Prevention (CSAP)
Substance Abuse and Mental Health Services Administration (SAMSHA)

Minor Regulatory Errors with Major Consequences

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Thu (Suzanne) Phan, PharmD
Pharmacist
Division of Legal & Regulatory Support (DLRS)
Office of Generic Drug Policy (OGDP) | OGD | CDER

Questions & Panel Discussion

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Churg (Stella) Chan, Nuri Tawwab

and

Heather Strandberg, PharmD
Pharmacist
DLRS | OGDP | OGD | CDER

Generic Drugs Forum – Day One - Session 3

Considerations when Submitting Proposed Excipient Levels in Inactive Ingredient Controlled Correspondences 

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Zakia R. Williams-Greene, PhD
Senior Pharmacologist
Division of Bioequivalence I (DBI)
OB | OGD | CDER

Assessment of Inactive Ingredients in Generic Drug Applications: Building a Global Understanding

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Pamela Dorsey, MS, PhD
Pharmacist
DBIII | OB | OGD | CDER

How to Leverage the Inactive Ingredient Database (IID) and Safety Justification 

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Qing Liu, PhD
Deputy Director
DBI | OB | OGD | CDER

And

Julia Yang, PhD
Pharmacologist
Division of Pharmacology/Toxicology Review (DPTR)
Office of Safety & Clinical Evaluation (OSCE) | OGD | CDER

Questions & Panel Discussion

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Zakia Williams-Greene, Pamela Dorsey, Julia Yang, and Qing Liu

Generic Drugs Forum – Day One - Session 4

Product Specific Guidance (PSG) Program Overview 

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Joseph Kotysbar, PharmD
Regulatory Health Project Manager
Office of Research and Standards (ORS) OGD | CDER

Pre-Abbreviated New Drug Application (ANDA) Meetings: Process and Best Practices 

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Caliope Sarago, MHSA 
Team Lead, Regulatory Health Project Manager
ORS | OGD | CDER

Experiences from Post-Complete Response Letter (CRL) Scientific Meetings in GDUFA III 

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Arun Agrawal, PhD
Pharmacologist
DBI | OB | OGD | CDER

Common Discrepancies Observed on the Form 356h with the Abbreviated New Drug Application (ANDA) Submission 

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Onyekachukwu (Onyeka) Ihezie, PharmD
Regulatory Business Process Manager
Division of Regulatory and Business Process Management I (DRBPMI)
OPRO | OPQ | CDER

And

Thaoly Nguyen, PharmD
Regulatory Business Process Manager
DRBPMIII | OPRO | OPQ | CDER

Questions, Panel Discussion & Closing 

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Joseph Kotysbar, Caliope Sarago, Arun Agrawal, Onyeka Ihezie, Thaoly Nguyen

and

Haitao Li, PhD
Supervisor
Division of Pharmaceutical Manufacturing Assessment V (DPMAV)
Office of Pharmaceutical Manufacturing Assessment (OPMA) 
OPQ | CDER


Day 2 Topics & Presentations

Speakers

Generic drugs Forum – Day Two – Session 1

General Quality Considerations of Drug Products Labeled for Alternate Dosing Administration

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Ravikanth Kona, PhD
Pharmaceutical Scientist
Division of Product Quality Assessment I (DPQA I)
Office of Product Quality Assessment I (OPQA I)
Office of Pharmaceutical Quality (OPQ) | CDER

Nitrosamine Related Guidance

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Reynolds (Rey) Cantave, PharmD
Senior Regulatory Health Project Manager
Enterprise Project Management Staff
Office of Quality Assurance (OQA) | OPQ | CDER

Bioequivalence Approaches for Nitrosamine Impacted Generic Drug Applications: Case Studies

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Paramjeet Kaur, PhD
Team Leader
Division of Bioequivalence II (DB II)
Office of Bioequivalence (OB)
Office of Generic Drugs (OGD) | CDER

Questions & Panel Discussion 

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Ravikanth Kona, Reynolds (Rey) Cantave, and Paramjeet Kaur 

Generic drugs Forum – Day Two – Session 2

Impact of ICH M13A Implementation on Bioequivalence Assessment: Removal of Data Due to Low Exposure 

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Diana Vivian, PhD
Associate Division Director
DBII | OB | OGD | CDER

ANDA Common Major Deficiencies

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Darby Kozak, PhD
Deputy Director
OGD | CDER

Common Bioequivalence (BE) Deficiencies Identified in ANDAs Associated with Solid Oral Extended-Release Drug Products in Various Therapeutic Areas 

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Juhyun Kim, PhD
Senior Pharmacologist
DBIII | OB | OGD | CDER

Common Clinical Deficiencies in Abbreviated New Drug Applications (ANDAs) Containing Comparative Clinical Endpoint Studies

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Ying Fan, PhD
Team Lead
Division of Clinical Review (DCR)
Office of Safety and Clinical Evaluation (OSCE)
OGD | CDER

Questions & Panel Discussion

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Diana Vivian, Darby Kozak, Juhyun Kim, and Ying Fan

Generic drugs Forum – Day Two – Session 3

GDUFA III Impact on Drug Master File (DMF) Assessment

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Jayani Perera, PhD
Senior Chemist
Division of Product Quality Assessment XIX (DPQAXIX)
Office of Product Quality Assessment III (OPQAIII)
OPQ | CDER

Common Deficiencies in Drug Master Files (DMFs) 

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David Green, MS
Senior Pharmaceutical Quality Assessor
DPQAXVII | OPQAIII | OPQ | OGD | CDER

Common (OPQ) Deficiencies in Abbreviated New Drug Applications (ANDAs)

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Fang Yuan, PhD
Senior Pharmaceutical Scientist
Immediate Office (IO)
OPQAI | OPQ | CDER

Navigating Challenges in Drug Manufacturing: Common Process Deficiencies and Pre-Approval Inspection Observations 

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Andrew Idzior
Chemist
Office of Pharmaceutical Manufacturing Assessment (OPMA)
OPQ | CDER

Questions & Panel Discussion

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Jayani Perera, David Green, Fang Yuan, Andrew Idzior, and Tahseen Mirza

Generic drugs Forum – Day Two – Session 4

Orange Book Marketing Status 

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Truong Quach, PharmD
Team Lead
DOBPRA | OGDP | OGD | CDER

Case Studies of Using Alternate Reference Products or Alternative Bioequivalence (BE) Approaches in Abbreviated New Drug Application (ANDA) Submissions 

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Xiaojian Jiang, PhD
Deputy Division Director
DBII | OB | OGD | CDER

Common Bioequivalence (BE) Information Requests (IRs): Tips for Facilitating the Review Process 

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Fang Lu, PhD
Team Leader
DBI | OB | OGD | CDER

Questions & Panel Discussion

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Truong Quach, Jennifer Miller, Xiaojian Jiang, and Fang Lu

Closing Remarks

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Kendra S. Stewart, RPh, PharmD
Captain | United States Public Health Service (USPHS)
Deputy Director for Operations
OGD | CDER

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About this Event (Hosted by CDER SBIA)

The annual Generic Drugs Forum is a two-day event designed to facilitate the development and approval of safe, effective, and high-quality generic medicines. This premier event brings together FDA subject matter experts from every aspect of the pre-ANDA and ANDA assessment programs, offering unparalleled insights and guidance. Attendees will gain practical regulatory knowledge to enhance their applications, streamline the assessment process, and reduce cycles. The forum's primary goal is to support prospective and current applicants in submitting complete and high-quality submissions, ultimately ensuring timely access to affordable medications that benefit public health.

Intended Audience

The generic drug industry, consultants, regulatory affairs professionals, or contractors with an emphasis on those who are:

  • involved in generic drug development
  • submitting or have submitted a generic drug application, amendment, supplement, or post-approval submission

FDA Resources

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