Forum | Mixed
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 | Darby Kozak, PhD Deputy Director Office of Generic Drugs (OGD) CDER |
Office of Pharmaceutical Quality (OPQ) Keynote - Recording | 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 View RecordingExternal Link Disclaimer | Download Slides 1 | Download Slides 2 | Edward (Ted) Sherwood Director Office of Regulatory Operations (ORO) OGD | CDER |
Request For Reconsideration: Process Overview and Best Practices for FDA Evaluation | 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 | Yi Zhang, PhD Associate Director Division of Bioequivalence III (DBIII) Office of Bioequivalence (OB) | OGD | CDER |
Questions & Panel Discussion | Ted Sherwood, Scott Vehovic, Joe Shin and Yi Zhang |
Generic Drugs Forum – Day One - Session 2 | |
Best Practices for Generic Drug Labeling | Churg (Stella) Chan, PharmD, BCPS Pharmacist Division of Labeling Review (DLR) ORO | OGD | CDER |
Project Managing Drug Assessors Under GDUFA III Regulations | 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 | Thu (Suzanne) Phan, PharmD Pharmacist Division of Legal & Regulatory Support (DLRS) Office of Generic Drug Policy (OGDP) | OGD | CDER |
Questions & Panel Discussion | Churg (Stella) Chan, Nuri Tawwab and Heather Strandberg, PharmD |
Generic Drugs Forum – Day One - Session 3 | |
Considerations when Submitting Proposed Excipient Levels in Inactive Ingredient Controlled Correspondences | 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 | Pamela Dorsey, MS, PhD Pharmacist DBIII | OB | OGD | CDER |
How to Leverage the Inactive Ingredient Database (IID) and Safety Justification | Qing Liu, PhD And Julia Yang, PhD |
Questions & Panel Discussion | Zakia Williams-Greene, Pamela Dorsey, Julia Yang, and Qing Liu |
Generic Drugs Forum – Day One - Session 4 | |
Product Specific Guidance (PSG) Program Overview | 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 | Caliope Sarago, MHSA Team Lead, Regulatory Health Project Manager ORS | OGD | CDER |
Experiences from Post-Complete Response Letter (CRL) Scientific Meetings in GDUFA III | Arun Agrawal, PhD Pharmacologist DBI | OB | OGD | CDER |
Common Discrepancies Observed on the Form 356h with the Abbreviated New Drug Application (ANDA) Submission | Onyekachukwu (Onyeka) Ihezie, PharmD And Thaoly Nguyen, PharmD |
Questions, Panel Discussion & Closing | Joseph Kotysbar, Caliope Sarago, Arun Agrawal, Onyeka Ihezie, Thaoly Nguyen and Haitao Li, PhD |
Day 2 Topics & Presentations | Speakers |
|---|---|
Generic drugs Forum – Day Two – Session 1 | |
General Quality Considerations of Drug Products Labeled for Alternate Dosing Administration | 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 | 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 | Paramjeet Kaur, PhD Team Leader Division of Bioequivalence II (DB II) Office of Bioequivalence (OB) Office of Generic Drugs (OGD) | CDER |
Questions & Panel Discussion | 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 | Diana Vivian, PhD Associate Division Director DBII | OB | OGD | CDER |
ANDA Common Major Deficiencies | 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 | Juhyun Kim, PhD Senior Pharmacologist DBIII | OB | OGD | CDER |
Common Clinical Deficiencies in Abbreviated New Drug Applications (ANDAs) Containing Comparative Clinical Endpoint Studies | Ying Fan, PhD Team Lead Division of Clinical Review (DCR) Office of Safety and Clinical Evaluation (OSCE) OGD | CDER |
Questions & Panel Discussion | 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 | 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) | David Green, MS Senior Pharmaceutical Quality Assessor DPQAXVII | OPQAIII | OPQ | OGD | CDER |
Common (OPQ) Deficiencies in Abbreviated New Drug Applications (ANDAs) | 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 | Andrew Idzior Chemist Office of Pharmaceutical Manufacturing Assessment (OPMA) OPQ | CDER |
Questions & Panel Discussion | Jayani Perera, David Green, Fang Yuan, Andrew Idzior, and Tahseen Mirza |
Generic drugs Forum – Day Two – Session 4 | |
Orange Book Marketing Status | 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 | Xiaojian Jiang, PhD Deputy Division Director DBII | OB | OGD | CDER |
Common Bioequivalence (BE) Information Requests (IRs): Tips for Facilitating the Review Process | Fang Lu, PhD Team Leader DBI | OB | OGD | CDER |
Questions & Panel Discussion | Truong Quach, Jennifer Miller, Xiaojian Jiang, and Fang Lu |
Closing Remarks | Kendra S. Stewart, RPh, PharmD Captain | United States Public Health Service (USPHS) Deputy Director for Operations OGD | CDER |
Visit CDER Small Business and Industry Assistance Page
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
- Product-Specific Guidances for Generic Drug Development
- Pharmaceutical Quality Resources
- Industry Resources
- Guidances Related to Generic Drugs (under topics, choose “generic drugs”)
- Federal Register Notices Related to Generic Drugs
- GDUFA Science and Research
- Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book